Primary ImmunodeficiencyPhase 1/2ASISinPINCT02123615
ASIS for GAMMAGARD in Primary Immunodeficiency
A Phase 1/2 study testing Gadolinium For abdomen, Gadolinium For lower back and Efficacy of Gammagard subcutaneously at Week 12 in people with Primary Immunodeficiency, run by ASIS Corporation at 1 site in United States.
Trial summary
ASIS Corporation (ASIS) has developed the only automatic injection system for delivery of injectable products to it's optimum/right spot, just outside of the fascia, which exists subdermally (between the skin and muscle). Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Immunodeficiency
- What is being tested?
- Gadolinium For abdomen, Gadolinium For lower back and Efficacy of Gammagard subcutaneously at Week 12
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Jun 2016
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Main Criteria for Inclusion: Eligible Ages: 12 Years to 65
- Genders Eligible for Study: Both
- Accepts Healthy Volunteers: Yes
- Must be outpatient, male or female, of any race, between 18 and 65 years of age.
- Must be able to understand the requirements of the study including maintaining a diary, and sign informed consent.
- Must be in good general health as determined by investigator.
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- If female of childbearing potential, must have negative pregnancy test result at screening visit and practice reliable method of contraception
- Inclusion Criteria for Primary Immunodeficiency in particular:
- Patients 12 years or older. This includes, but is not limited to, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies1,2.
Who cannot join
- Exclusion Criteria for Primary Immunodeficiency in particular:
- Females who are pregnant, nursing, or planning a pregnancy during the study period or who are not using a reliable means of contraception.
Trial locations and contacts
1 site in 1 country.
United States1 site
Automatic Subdermal Injector System, Inc
Westminster, California, 92683
Li Nguyen, MD, 714-453-7857, dr.li.nguyen@asis-inc.com
Thanh Phung, MD, (714)-893-1915, thanhphung@idit-inc.com
About this study
ASIS Corporation (ASIS) has developed the only automatic injection system for delivery of injectable products to it's optimum/right spot, just outside of the fascia, which exists subdermally (between the skin and muscle). Bloodless basically implies longer lasting medicinal effects, and minimal side effects - advantages that reflect the NIH mission of enhancing health, lengthening life, and reducing the burdens of illness and disability. ASIS device is stabilized on the surface of the skin with negative pressure and emits an electrical current to create a bloodless cavity subdermally. ASIS device correctly, automatically, and consistently delivers therapeutic agents, yet requiring little skill of a practitioner - providing the steady and safe infusion into subdermal bloodless space of virtually any injectable product in addition to Botox, including GAMMAGARD LIQUID, Enbrel, Insulin, and Fillers, etc. According to the FDA, "This innovation will have major impact on the healthcare industry."
Read the detailed description
Aim 1 would require 6 months, to demonstrate ASIS device's consistent performance on 60 subjects with Primary Immunodeficiency (PI), and the particular skin affected by this disease.
30 subjects will receive Gadolinium subcutaneously, and 30 subjects will receive Gadolinium subdermally with ASIS device. An MRI will be taken promptly after Gadolinium injection, as starting reference, to which subsequent MRI taken at 6 hrs, 12 hrs, and 24 hrs later will be compared for Persistent %. Since there isn't a way to measure level of Gadolinium within it, or any other (e.g.
GAMMAGARD) for that matter, at least the Prolongation of Gadolinium may be approximated by the greater or longer Persistent % on MRI. However, this approximation can only work if the variables are minimized to the same population with Primary Immunodeficiency (PI), and the particular skin affected by it. Case in point, Primary Immunodeficiency (PI) patients are prone to infection, and tend to have scared skin with less vascularity, so expectantly will have prolonged Gadolinium subcutaneously Persistent %, which will be very different from the skin of normal patients, while the Gadolinium subdermally Persistent % may or may not change. Therefore, the Relative Prolongation Ability Score or total Persistent % subdermally over that of total Persistent % subcutaneously, will be different and very specific for the particular skin affected by Primary Immunodeficiency. However, they are valuable indicators that will help us modify the GAMMAGARD dosage and duration to inject into that "unknown" subdermal space for Aim 2.
Aim 2 would require 12 months, using GAMMAGARD, instead of Gadolinium, to demonstrate the advantages of ASIS device subdermally over subcutaneously, for the same Primary Immunodeficiency subjects. Of course that Relative Prolongation Ability Score in Aim1 will be valuable, but it isn't absolutely required to start Aim 2, because GAMMAGARD's Pharmacokinetics will be studied anyway, by following Peak and Trough levels of immunoglobulin G.
However, the Pharmacokinetics of subdermally injected GAMMAGARD will be just dependent on GAMMAGARD's diffusion out of that subdermal bloodless space; therefore, if GAMMAGARD getting into the bloodstream becomes so severely inhibited, then we can just change the osmolality of GAMMAGARD in the end. The therapeutic advantages of GAMMAGARD with ASIS device subdermally over subcutaneously will also be studied by comparing the reduction of Validated Acute Serious Bacterial Infections, adverse reactions, and injection site pain.
- Conditions
- Primary Immunodeficiency
- Being tested
- Gadolinium For abdomen, Gadolinium For lower back, Efficacy of Gammagard subcutaneously at Week 12, Efficacy of Gammagard subcutaneously at Week 24, Efficacy of Gammagard subcutaneously at Week 36
- Keywords
- Primary Immunodeficiency, Subdermal bloodless space, Subdermal injection, Subcutaneous injection, Injectable electromyography needle, Electrical stimulation, MRI with Gadolinium
- Medical subject headings
- Primary Immunodeficiency Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gadolinium For abdomenDrug
Also called Gadolinium Magnevist® (gadopentetate dimeglumine)
Gadolinium 1cc/ diluted with 19cc normal saline (for <40kg) or 29cc normal saline (for >40kg) subdermally with ASIS Device for 30 patients.
Gadolinium For abdomen Total Persistent % subdermally on MRI at 6 hrs, 12 hrs, and 24 hrs.
Gadolinium For abdomenDrug
Also called Gadolinium Magnevist® (gadopentetate dimeglumine)
Gadolinium 1cc/ diluted with 19cc normal saline (for <40kg) or 29cc normal saline (for >40kg) subcutaneously for 30 patients.
Gadolinium For abdomen Total Persistent % subcutaneously on MRI at 6 hrs, 12 hrs, and 24 hrs.
Gadolinium For abdomenDrug
Also called Gadolinium Magnevist® (gadopentetate dimeglumine)
Gadolinium For abdomen Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium subcutaneously on MRI.
Gadolinium For lower backDrug
Also called Gadolinium Magnevist® (gadopentetate dimeglumine)
Gadolinium For lower back Total Persistent % subdermally on MRI at 6 hrs, 12 hrs, and 24 hrs. Gadolinium 1cc/ diluted with 19cc normal saline (for <40kg) or 29cc normal saline (for >40kg) subdermally with ASIS Device for 30 patients.
Gadolinium For lower backDrug
Also called Gadolinium Magnevist® (gadopentetate dimeglumine)
Gadolinium For lower back Total cumulative Persistent % of Gadolinium subcutaneously on MRI at 6 hrs, 12 hrs, and 24 hrs. Gadolinium 1cc/ diluted with 19cc normal saline (for <40kg) or 29cc normal saline (for >40kg) subcutaneously for 30 patients.
Gadolinium For lower backDrug
Also called Gadolinium Magnevist® (gadopentetate dimeglumine)
Gadolinium For lower back Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium subcutaneously on MRI .
Efficacy of Gammagard subcutaneously at Week 12Drug
Also called Gammagard [Immune Globulin Infusion (Human)]
subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 12.
Efficacy of Gammagard subcutaneously at Week 12Drug
Also called Gammagard [Immune Globulin Infusion (Human)]
Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 12.
Efficacy of Gammagard subcutaneously at Week 12Drug
Also called Gammagard [Immune Globulin Infusion (Human)]
subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12.
Efficacy of Gammagard subcutaneously at Week 12Drug
Also called Gammagard [Immune Globulin Infusion (Human)]
Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12.
Efficacy of Gammagard subcutaneously at Week 12Drug
Also called Gammagard [Immune Globulin Infusion (Human)]
subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 12.
Efficacy of Gammagard subcutaneously at Week 12Drug
Also called Gammagard [Immune Globulin Infusion (Human)]
Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 12.
Efficacy of Gammagard subcutaneously at Week 12Drug
Also called Gammagard [Immune Globulin Infusion (Human)]
(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12.
Efficacy of Gammagard subcutaneously at Week 12Drug
Also called Gammagard [Immune Globulin Infusion (Human)]
Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12.
Efficacy of Gammagard subcutaneously at Week 24Drug
Also called Gammagard [Immune Globulin Infusion (Human)]
subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 24.
Efficacy of Gammagard subcutaneously at Week 24Drug
Also called Gammagard [Immune Globulin Infusion (Human)]
Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 24.
Efficacy of Gammagard subcutaneously at Week 24Drug
Also called Gammagard [Immune Globulin Infusion (Human)]
subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 24.
Efficacy of Gammagard subcutaneously at Week 24Drug
Also called Gammagard [Immune Globulin Infusion (Human)]
Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 24.
Efficacy of Gammagard subcutaneously at Week 24Drug
Also called Gammagard [Immune Globulin Infusion (Human)]
subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 24.
Efficacy of Gammagard subcutaneously at Week 24Drug
Also called Gammagard [Immune Globulin Infusion (Human)]
Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 24
Efficacy of Gammagard subcutaneously at Week 24Drug
Also called Gammagard [Immune Globulin Infusion (Human)]
(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 24.
Efficacy of Gammagard subcutaneously at Week 24Drug
Also called Gammagard [Immune Globulin Infusion (Human)]
Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 24.
Efficacy of Gammagard subcutaneously at Week 36Drug
Also called Gammagard [Immune Globulin Infusion (Human)]
subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 36.
Efficacy of Gammagard subcutaneously at Week 36Drug
Also called Gammagard [Immune Globulin Infusion (Human)]
Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 36.
Efficacy of Gammagard subcutaneously at Week 36Drug
Also called Gammagard [Immune Globulin Infusion (Human)]
subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 36.
Efficacy of Gammagard subcutaneously at Week 36Drug
Also called Gammagard [Immune Globulin Infusion (Human)]
Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 36.
Efficacy of Gammagard subcutaneously at Week 36Drug
Also called Gammagard [Immune Globulin Infusion (Human)]
subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 36.
Efficacy of Gammagard subdermally at Week 36Drug
Also called Gammagard [Immune Globulin Infusion (Human)]
Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 36.
Efficacy of Gammagard subdermally at Week 36Drug
Also called Gammagard [Immune Globulin Infusion (Human)]
(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 36.
Efficacy of Gammagard subdermally at Week 36Drug
Also called Gammagard [Immune Globulin Infusion (Human)]
Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 36.
Efficacy of Gammagard subdermally at Week 12Drug
Also called Gammagard [Immune Globulin Infusion (Human)]
subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 12
Efficacy of Gammagard subdermally at Week 12Drug
Also called Gammagard [Immune Globulin Infusion (Human)]
Annual rate of any infections as Efficacy of Gammagard subdermally at Week 12
Efficacy of Gammagard subdermally at Week 12Drug
Also called Gammagard [Immune Globulin Infusion (Human)]
subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 12
Efficacy of Gammagard subdermally at Week 12Drug
Also called Gammagard [Immune Globulin Infusion (Human)]
Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 12
Efficacy of Gammagard subdermally at Week 12Drug
Also called Gammagard [Immune Globulin Infusion (Human)]
subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 12
Efficacy of Gammagard subdermally at Week 12Drug
Also called Gammagard [Immune Globulin Infusion (Human)]
Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 12
Efficacy of Gammagard subdermally at Week 12Drug
Also called Gammagard [Immune Globulin Infusion (Human)]
(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 12
Efficacy of Gammagard subdermally at Week 12Drug
Also called Gammagard [Immune Globulin Infusion (Human)]
Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 12.
Efficacy of Gammagard subdermally at Week 24Drug
Also called Gammagard [Immune Globulin Infusion (Human)]
subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 24.
Efficacy of Gammagard subdermally at Week 24Drug
Also called Gammagard [Immune Globulin Infusion (Human)]
Annual rate of any infections as Efficacy of Gammagard subdermally at Week 24.
Efficacy of Gammagard subdermally at Week 24Drug
Also called Gammagard [Immune Globulin Infusion (Human)]
subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 24.
Efficacy of Gammagard subdermally at Week 24Drug
Also called Gammagard [Immune Globulin Infusion (Human)]
Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 24.
Efficacy of Gammagard subdermally at Week 24Drug
Also called Gammagard [Immune Globulin Infusion (Human)]
subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 24.
Efficacy of Gammagard subdermally at Week 24Drug
Also called Gammagard [Immune Globulin Infusion (Human)]
Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 24.
Efficacy of Gammagard subdermally at Week 24Drug
Also called Gammagard [Immune Globulin Infusion (Human)]
(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 24.
Efficacy of Gammagard subdermally at Week 24Drug
Also called Gammagard [Immune Globulin Infusion (Human)]
Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 24.
Efficacy of Gammagard subdermally at Week 36Drug
Also called Gammagard [Immune Globulin Infusion (Human)]
subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 36.
Efficacy of Gammagard subdermally at Week 36Drug
Also called Gammagard [Immune Globulin Infusion (Human)]
Annual rate of any infections as Efficacy of Gammagard subdermally at Week 36.
Efficacy of Gammagard subdermally at Week 36Drug
Also called Gammagard [Immune Globulin Infusion (Human)]
subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 36.
Efficacy of Gammagard subdermally at Week 36Drug
Also called Gammagard [Immune Globulin Infusion (Human)]
Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 36.
Efficacy of Gammagard subdermally at Week 36Drug
Also called Gammagard [Immune Globulin Infusion (Human)]
subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 36.
Efficacy of Gammagard subdermally at Week 36Drug
Also called Gammagard [Immune Globulin Infusion (Human)]
Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 36.
Efficacy of Gammagard subdermally at Week 36Drug
Also called Gammagard [Immune Globulin Infusion (Human)]
(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 36.
Efficacy of Gammagard subdermally at Week 36Drug
Also called Gammagard [Immune Globulin Infusion (Human)]
Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 36.
Adverse Reactions of Gammagard subcutaneously at Week 12Drug
Also called Gammagard [Immune Globulin Infusion (Human)]
Adverse Reactions of Gammagard subcutaneously at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Adverse Reactions of Gammagard subcutaneously at Week 24Drug
Also called Gammagard [Immune Globulin Infusion (Human)]
Adverse Reactions of Gammagard subcutaneously at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Adverse Reactions of Gammagard subcutaneously at Week 36Drug
Also called Gammagard [Immune Globulin Infusion (Human)]
Adverse Reactions of Gammagard subcutaneously at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Adverse Reactions of Gammagard subdermally at Week 12Drug
Also called Gammagard [Immune Globulin Infusion (Human)]
Adverse Reactions of Gammagard subdermally at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain
Adverse Reactions of Gammagard subdermally at Week 24Drug
Also called Gammagard [Immune Globulin Infusion (Human)]
Adverse Reactions of Gammagard subdermally at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Adverse Reactions of Gammagard subdermally at Week 36Drug
Also called Gammagard [Immune Globulin Infusion (Human)]
Adverse Reactions of Gammagard subdermally at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
| Study group | Role | What they receive |
|---|---|---|
| Gadolinium For abdomen | Experimental | Gadolinium For abdomen Total Persistent % subdermally, For abdomen Total Persistent % subcutaneously, and For abdomen Relative Prolongation Ability Score.
Gadolinium Magnevist® (gadopentetate dimeglumine)
1cc/ diluted with 19cc normal saline (for <40kg) or 29cc normal saline (for >40kg), subcutaneously for 30 patients, and subdermally with ASIS Device for 30 patients. Receives: Drug: Gadolinium For abdomen; Drug: Gadolinium For lower back |
| Gadolinium For lower back | Experimental | 1cc/ diluted with 19cc normal saline (for <40kg) or 29cc normal saline (for >40kg), subcutaneously for 30 patients, and subdermally with ASIS Device for 30 patients.
Gadolinium For lower back Total Persistent % subdermally, For lower back Total Persistent % subcutaneously, and For lower back Relative Prolongation Ability Score. Receives: Drug: Gadolinium For abdomen; Drug: Gadolinium For lower back |
| subjects (%) of any infections | Experimental | subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 12, Efficacy of Gammagard subcutaneously at Week 24, and Efficacy of Gammagard subcutaneously at Week 36, vs. Efficacy of Gammagard subdermally at Week 12, Efficacy of Gammagard subdermally at Week 24, and Efficacy of Gammagard subdermally at Week 36. Receives: Drug: Efficacy of Gammagard subcutaneously at Week 12; Drug: Efficacy of Gammagard subcutaneously at Week 24; Drug: Efficacy of Gammagard subcutaneously at Week 36; Drug: Efficacy of Gammagard subdermally at Week 36; Drug: Efficacy of Gammagard subdermally at Week 12; Drug: Efficacy of Gammagard subdermally at Week 24 |
| Annual rate of any infections | Experimental | Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 12, Efficacy of Gammagard subcutaneously at Week 24, and Efficacy of Gammagard subcutaneously at Week 36, vs. Efficacy of Gammagard subdermally at Week 12, Efficacy of Gammagard subdermally at Week 24, and Efficacy of Gammagard subdermally at Week 36. Receives: Drug: Efficacy of Gammagard subcutaneously at Week 12; Drug: Efficacy of Gammagard subcutaneously at Week 24; Drug: Efficacy of Gammagard subcutaneously at Week 36; Drug: Efficacy of Gammagard subdermally at Week 36; Drug: Efficacy of Gammagard subdermally at Week 12; Drug: Efficacy of Gammagard subdermally at Week 24 |
| subjects (%) with Antibiotic use | Experimental | subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12, Efficacy of Gammagard subcutaneously at Week 24, and Efficacy of Gammagard subcutaneously at Week 36, vs. Efficacy of Gammagard subdermally at Week 12, Efficacy of Gammagard subdermally at Week 24, and Efficacy of Gammagard subdermally at Week 36. Receives: Drug: Efficacy of Gammagard subcutaneously at Week 12; Drug: Efficacy of Gammagard subcutaneously at Week 24; Drug: Efficacy of Gammagard subcutaneously at Week 36; Drug: Efficacy of Gammagard subdermally at Week 36; Drug: Efficacy of Gammagard subdermally at Week 12; Drug: Efficacy of Gammagard subdermally at Week 24 |
| Annual rate with Antibiotic use | Experimental | Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12, Efficacy of Gammagard subcutaneously at Week 24, and Efficacy of Gammagard subcutaneously at Week 36, vs. Efficacy of Gammagard subdermally at Week 12, Efficacy of Gammagard subdermally at Week 24, and Efficacy of Gammagard subdermally at Week 36. Receives: Drug: Efficacy of Gammagard subcutaneously at Week 12; Drug: Efficacy of Gammagard subcutaneously at Week 24; Drug: Efficacy of Gammagard subcutaneously at Week 36; Drug: Efficacy of Gammagard subdermally at Week 36; Drug: Efficacy of Gammagard subdermally at Week 12; Drug: Efficacy of Gammagard subdermally at Week 24 |
| subjects (%) with Days out of work | Experimental | subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 12, Efficacy of Gammagard subcutaneously at Week 24, and Efficacy of Gammagard subcutaneously at Week 36, vs. Efficacy of Gammagard subdermally at Week 12, Efficacy of Gammagard subdermally at Week 24, and Efficacy of Gammagard subdermally at Week 36. Receives: Drug: Efficacy of Gammagard subcutaneously at Week 12; Drug: Efficacy of Gammagard subcutaneously at Week 24; Drug: Efficacy of Gammagard subcutaneously at Week 36; Drug: Efficacy of Gammagard subdermally at Week 36; Drug: Efficacy of Gammagard subdermally at Week 12; Drug: Efficacy of Gammagard subdermally at Week 24 |
| Annual rate with Days out of work | Experimental | Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 12, Efficacy of Gammagard subcutaneously at Week 24, and Efficacy of Gammagard subcutaneously at Week 36, vs. Efficacy of Gammagard subdermally at Week 12, Efficacy of Gammagard subdermally at Week 24, and Efficacy of Gammagard subdermally at Week 36. Receives: Drug: Efficacy of Gammagard subcutaneously at Week 12; Drug: Efficacy of Gammagard subcutaneously at Week 24; Drug: Efficacy of Gammagard subcutaneously at Week 36; Drug: Efficacy of Gammagard subdermally at Week 36; Drug: Efficacy of Gammagard subdermally at Week 12; Drug: Efficacy of Gammagard subdermally at Week 24 |
| (%) with hospitalized infections | Experimental | (%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12, Efficacy of Gammagard subcutaneously at Week 24, and Efficacy of Gammagard subcutaneously at Week 36, vs. Efficacy of Gammagard subdermally at Week 12, Efficacy of Gammagard subdermally at Week 24, and Efficacy of Gammagard subdermally at Week 36. Receives: Drug: Efficacy of Gammagard subcutaneously at Week 12; Drug: Efficacy of Gammagard subcutaneously at Week 24; Drug: Efficacy of Gammagard subcutaneously at Week 36; Drug: Efficacy of Gammagard subdermally at Week 36; Drug: Efficacy of Gammagard subdermally at Week 12; Drug: Efficacy of Gammagard subdermally at Week 24 |
| Annual rate hospitalized infections | Experimental | Annual rate hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12, Efficacy of Gammagard subcutaneously at Week 24, and Efficacy of Gammagard subcutaneously at Week 36, vs. Efficacy of Gammagard subdermally at Week 12, Efficacy of Gammagard subdermally at Week 24, and Efficacy of Gammagard subdermally at Week 36. Receives: Drug: Efficacy of Gammagard subcutaneously at Week 12; Drug: Efficacy of Gammagard subcutaneously at Week 24; Drug: Efficacy of Gammagard subcutaneously at Week 36; Drug: Efficacy of Gammagard subdermally at Week 36; Drug: Efficacy of Gammagard subdermally at Week 12; Drug: Efficacy of Gammagard subdermally at Week 24 |
| Adverse Injection Local Reactions | Experimental | Adverse Injection Local Reactions as Adverse Reactions of Gammagard subcutaneously at Week 12, Adverse Reactions of Gammagard subcutaneously at Week 24, and Adverse Reactions of Gammagard subcutaneously at Week 36, vs. Adverse Reactions of Gammagard subdermally at Week 12, Adverse Reactions of Gammagard subdermally at Week 24, and Adverse Reactions of Gammagard subdermally at Week 36. Receives: Drug: Adverse Reactions of Gammagard subcutaneously at Week 12; Drug: Adverse Reactions of Gammagard subcutaneously at Week 24; Drug: Adverse Reactions of Gammagard subcutaneously at Week 36; Drug: Adverse Reactions of Gammagard subdermally at Week 12; Drug: Adverse Reactions of Gammagard subdermally at Week 24; Drug: Adverse Reactions of Gammagard subdermally at Week 36 |
| Adverse Reactions Headache | Experimental | Headache as Adverse Reactions of Gammagard subcutaneously at Week 12, Adverse Reactions of Gammagard subcutaneously at Week 24, and Adverse Reactions of Gammagard subcutaneously at Week 36, vs. Adverse Reactions of Gammagard subdermally at Week 12, Adverse Reactions of Gammagard subdermally at Week 24, and Adverse Reactions of Gammagard subdermally at Week 36. Receives: Drug: Adverse Reactions of Gammagard subcutaneously at Week 12; Drug: Adverse Reactions of Gammagard subcutaneously at Week 24; Drug: Adverse Reactions of Gammagard subcutaneously at Week 36; Drug: Adverse Reactions of Gammagard subdermally at Week 12; Drug: Adverse Reactions of Gammagard subdermally at Week 24; Drug: Adverse Reactions of Gammagard subdermally at Week 36 |
| Adverse Reactions Fever | Experimental | Fever as Adverse Reactions of Gammagard subcutaneously at Week 12, Adverse Reactions of Gammagard subcutaneously at Week 24, and Adverse Reactions of Gammagard subcutaneously at Week 36, vs. Adverse Reactions of Gammagard subdermally at Week 12, Adverse Reactions of Gammagard subdermally at Week 24, and Adverse Reactions of Gammagard subdermally at Week 36. Receives: Drug: Adverse Reactions of Gammagard subcutaneously at Week 12; Drug: Adverse Reactions of Gammagard subcutaneously at Week 24; Drug: Adverse Reactions of Gammagard subcutaneously at Week 36; Drug: Adverse Reactions of Gammagard subdermally at Week 12; Drug: Adverse Reactions of Gammagard subdermally at Week 24; Drug: Adverse Reactions of Gammagard subdermally at Week 36 |
| Adverse Reactions Nausea | Experimental | Nausea as Adverse Reactions of Gammagard subcutaneously at Week 12, Adverse Reactions of Gammagard subcutaneously at Week 24, and Adverse Reactions of Gammagard subcutaneously at Week 36, vs. Adverse Reactions of Gammagard subdermally at Week 12, Adverse Reactions of Gammagard subdermally at Week 24, and Adverse Reactions of Gammagard subdermally at Week 36. Receives: Drug: Adverse Reactions of Gammagard subcutaneously at Week 12; Drug: Adverse Reactions of Gammagard subcutaneously at Week 24; Drug: Adverse Reactions of Gammagard subcutaneously at Week 36; Drug: Adverse Reactions of Gammagard subdermally at Week 12; Drug: Adverse Reactions of Gammagard subdermally at Week 24; Drug: Adverse Reactions of Gammagard subdermally at Week 36 |
| Adverse Reactions Vomiting | Experimental | Vomiting as Adverse Reactions of Gammagard subcutaneously at Week 12, Adverse Reactions of Gammagard subcutaneously at Week 24, and Adverse Reactions of Gammagard subcutaneously at Week 36, vs. Adverse Reactions of Gammagard subdermally at Week 12, Adverse Reactions of Gammagard subdermally at Week 24, and Adverse Reactions of Gammagard subdermally at Week 36. Receives: Drug: Adverse Reactions of Gammagard subcutaneously at Week 12; Drug: Adverse Reactions of Gammagard subcutaneously at Week 24; Drug: Adverse Reactions of Gammagard subcutaneously at Week 36; Drug: Adverse Reactions of Gammagard subdermally at Week 12; Drug: Adverse Reactions of Gammagard subdermally at Week 24; Drug: Adverse Reactions of Gammagard subdermally at Week 36 |
| Adverse Reactions Fatigue | Experimental | Fatigue as Adverse Reactions of Gammagard subcutaneously at Week 12, Adverse Reactions of Gammagard subcutaneously at Week 24, and Adverse Reactions of Gammagard subcutaneously at Week 36, vs. Adverse Reactions of Gammagard subdermally at Week 12, Adverse Reactions of Gammagard subdermally at Week 24, and Adverse Reactions of Gammagard subdermally at Week 36. Receives: Drug: Adverse Reactions of Gammagard subcutaneously at Week 12; Drug: Adverse Reactions of Gammagard subcutaneously at Week 24; Drug: Adverse Reactions of Gammagard subcutaneously at Week 36; Drug: Adverse Reactions of Gammagard subdermally at Week 12; Drug: Adverse Reactions of Gammagard subdermally at Week 24; Drug: Adverse Reactions of Gammagard subdermally at Week 36 |
| Adverse Reactions Diarrhea | Experimental | Diarrhea as Adverse Reactions of Gammagard subcutaneously at Week 12, Adverse Reactions of Gammagard subcutaneously at Week 24, and Adverse Reactions of Gammagard subcutaneously at Week 36, vs. Adverse Reactions of Gammagard subdermally at Week 12, Adverse Reactions of Gammagard subdermally at Week 24, and Adverse Reactions of Gammagard subdermally at Week 36. Receives: Drug: Adverse Reactions of Gammagard subcutaneously at Week 12; Drug: Adverse Reactions of Gammagard subcutaneously at Week 24; Drug: Adverse Reactions of Gammagard subcutaneously at Week 36; Drug: Adverse Reactions of Gammagard subdermally at Week 12; Drug: Adverse Reactions of Gammagard subdermally at Week 24; Drug: Adverse Reactions of Gammagard subdermally at Week 36 |
| Adverse Reactions Asthma | Experimental | Asthma as Adverse Reactions of Gammagard subcutaneously at Week 12, Adverse Reactions of Gammagard subcutaneously at Week 24, and Adverse Reactions of Gammagard subcutaneously at Week 36, vs. Adverse Reactions of Gammagard subdermally at Week 12, Adverse Reactions of Gammagard subdermally at Week 24, and Adverse Reactions of Gammagard subdermally at Week 36. Receives: Drug: Adverse Reactions of Gammagard subcutaneously at Week 12; Drug: Adverse Reactions of Gammagard subcutaneously at Week 24; Drug: Adverse Reactions of Gammagard subcutaneously at Week 36; Drug: Adverse Reactions of Gammagard subdermally at Week 12; Drug: Adverse Reactions of Gammagard subdermally at Week 24; Drug: Adverse Reactions of Gammagard subdermally at Week 36 |
| Adverse Reactions Oropharyngeal | Experimental | Oropharyngeal as Adverse Reactions of Gammagard subcutaneously at Week 12, Adverse Reactions of Gammagard subcutaneously at Week 24, and Adverse Reactions of Gammagard subcutaneously at Week 36, vs. Adverse Reactions of Gammagard subdermally at Week 12, Adverse Reactions of Gammagard subdermally at Week 24, and Adverse Reactions of Gammagard subdermally at Week 36. Receives: Drug: Adverse Reactions of Gammagard subcutaneously at Week 12; Drug: Adverse Reactions of Gammagard subcutaneously at Week 24; Drug: Adverse Reactions of Gammagard subcutaneously at Week 36; Drug: Adverse Reactions of Gammagard subdermally at Week 12; Drug: Adverse Reactions of Gammagard subdermally at Week 24; Drug: Adverse Reactions of Gammagard subdermally at Week 36 |
| Adverse Reactions Abdominal Pain | Experimental | Abdominal Pain as Adverse Reactions of Gammagard subcutaneously at Week 12, Adverse Reactions of Gammagard subcutaneously at Week 24, and Adverse Reactions of Gammagard subcutaneously at Week 36, vs. Adverse Reactions of Gammagard subdermally at Week 12, Adverse Reactions of Gammagard subdermally at Week 24, and Adverse Reactions of Gammagard subdermally at Week 36. Receives: Drug: Adverse Reactions of Gammagard subcutaneously at Week 12; Drug: Adverse Reactions of Gammagard subcutaneously at Week 24; Drug: Adverse Reactions of Gammagard subcutaneously at Week 36; Drug: Adverse Reactions of Gammagard subdermally at Week 12; Drug: Adverse Reactions of Gammagard subdermally at Week 24; Drug: Adverse Reactions of Gammagard subdermally at Week 36 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative Prolongation Ability Score for Gadolinium subdermally injected
Gadolinium will be injected with ASIS subdermally (30) or conventional subcutaneous (30) for 60 adult subjects with Primary Immunodeficiency. The first MRI taken promptly after Gadolinium injection for each patient would be his or her reference of 100% Persistent, to which his or her subsequent MRI taken @ 6 hr, @ 12 hr, and @24hr later will be compared for Persistent %. This approximation can only work if the variables are minimized to the same population with Primary Immunodeficiency. The Relative Prolongation Ability Score or total Persistent % subdermally over total Persistent % subcutaneously, in Primary Immunodeficiency will be very valuable indicators for us to modify the GAMMAGARD dosage and duration for testing with that "unknown" subdermal bloodless space in Aim 2.
Measured: 6 months
Secondary outcomes (1)
Efficacy of GAMMAGARD subcutaneously vs. subdermally in Primary Immunodeficiency
The therapeutic efficacy of GAMMAGARD, in terms of reduction of Validated Acute Serious Bacterial Infections will be compared, eg. subjects (%) and Annual rate of any infections, subjects (%) and Annual rate of Antibiotic use, subjects (%) and Annual rate with Days out of work, subjects (%) and Annual rate of hospitalized infections, to demonstrate the advantages of ASIS device subdermally over subcutaneously for GAMMAGARD at Week 12, 24, and 36.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2014 (estimated)
- Study startJan 2016
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Primary ImmunodeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ASIS Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Li Nguyen, MD, Principal investigator, AUTOMATIC SUBDERMAL INJECTOR SYSTEM INCThanh Phung, MD, Principal investigator, AUTOMATIC SUBDERMAL INJECTOR SYSTEM, INCHanh Nguyen, MD, Principal investigator, AUTOMATIC SUBDERMAL INJECTOR SYSTEM,INC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02123615
- Sponsor's protocol ID
- NCTEB017805
- Other IDs
- 1R01EB017805
- Acronym
- ASISinPI
- Status last verified
- Jun 2015
- First submitted
- 11 Apr 2014
- Last updated
- 24 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Paonessa DF, Goldstein JC. Anatomy and physiology of head and neck infections (with emphasis on the fascia of the face and neck). Otolaryngol Clin North Am. 1976 Oct;9(3):561-80. No abstract available.
PubMed 980495Magnevist (gadopentetate dimeglumine) Injection Product Information: http://pharma.bayer.com/scripts/pages/en/products/diagnostic_imaging/index.php
Botox (onabotulinumtoxinA) Product Information: http://www.botoxcosmetic.com/botox_physician_info/Clinical_Information.aspx http://www.clinicaltrials.gov/ct2/show/NCT01313767?term=Botox+pi&rank=1
GAMMAGARD LIQUID Comparison of Intravenous and Subcutaneous Administration in Primary Immunodeficiency Diseases (PID): http://www.clinicaltrials.gov/ct2/show/NCT00546871?term=Gammagard+subcutaneous&rank=5
Daw Z, Padmore R, Neurath D, Cober N, Tokessy M, Desjardins D, Olberg B, Tinmouth A, Giulivi A. Hemolytic transfusion reactions after administration of intravenous immune (gamma) globulin: a case series analysis. Transfusion. 2008 Aug;48(8):1598-601. doi: 10.1111/j.1537-2995.2008.01721.x. Epub 2008 May 2.
PubMed 18466176Mignogna MD, Fortuna G, Ruoppo E, Adamo D, Leuci S, Fedele S. Variations in serum hemoglobin, albumin, and electrolytes in patients receiving intravenous immunoglobulin therapy: a real clinical threat? Am J Clin Dermatol. 2007;8(5):291-9. doi: 10.2165/00128071-200708050-00004.
PubMed 17902731Kreil TR, Berting A, Kistner O, Kindermann J. West Nile virus and the safety of plasma derivatives: verification of high safety margins, and the validity of predictions based on model virus data. Transfusion. 2003 Aug;43(8):1023-8. doi: 10.1046/j.1537-2995.2003.00496.x.
PubMed 12869106Ochs HD, Gupta S, Kiessling P, Nicolay U, Berger M; Subcutaneous IgG Study Group. Safety and efficacy of self-administered subcutaneous immunoglobulin in patients with primary immunodeficiency diseases. J Clin Immunol. 2006 May;26(3):265-73. doi: 10.1007/s10875-006-9021-7.
PubMed 16783465Gardulf A, Nicolay U, Asensio O, Bernatowska E, Bock A, Carvalho BC, Granert C, Haag S, Hernandez D, Kiessling P, Kus J, Pons J, Niehues T, Schmidt S, Schulze I, Borte M. Rapid subcutaneous IgG replacement therapy is effective and safe in children and adults with primary immunodeficiencies--a prospective, multi-national study. J Clin Immunol. 2006 Mar;26(2):177-85. doi: 10.1007/s10875-006-9002-x. Epub 2006 Apr 26.
PubMed 16758340Orange JS, Hossny EM, Weiler CR, Ballow M, Berger M, Bonilla FA, Buckley R, Chinen J, El-Gamal Y, Mazer BD, Nelson RP Jr, Patel DD, Secord E, Sorensen RU, Wasserman RL, Cunningham-Rundles C; Primary Immunodeficiency Committee of the American Academy of Allergy, Asthma and Immunology. Use of intravenous immunoglobulin in human disease: a review of evidence by members of the Primary Immunodeficiency Committee of the American Academy of Allergy, Asthma and Immunology. J Allergy Clin Immunol. 2006 Apr;117(4 Suppl):S525-53. doi: 10.1016/j.jaci.2006.01.015.
PubMed 16580469Bonilla FA, Bernstein IL, Khan DA, Ballas ZK, Chinen J, Frank MM, Kobrynski LJ, Levinson AI, Mazer B, Nelson RP Jr, Orange JS, Routes JM, Shearer WT, Sorensen RU; American Academy of Allergy, Asthma and Immunology; American College of Allergy, Asthma and Immunology; Joint Council of Allergy, Asthma and Immunology. Practice parameter for the diagnosis and management of primary immunodeficiency. Ann Allergy Asthma Immunol. 2005 May;94(5 Suppl 1):S1-63. doi: 10.1016/s1081-1206(10)61142-8. No abstract available.
PubMed 15945566Kahwaji J, Barker E, Pepkowitz S, Klapper E, Villicana R, Peng A, Chang R, Jordan SC, Vo AA. Acute hemolysis after high-dose intravenous immunoglobulin therapy in highly HLA sensitized patients. Clin J Am Soc Nephrol. 2009 Dec;4(12):1993-7. doi: 10.2215/CJN.04540709. Epub 2009 Oct 15.
PubMed 19833910
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASIS for GAMMAGARD in Primary Immunodeficiency
- ClinicalTrials.gov ID
- NCT02123615
- Acronym / sponsor ID
- ASISinPI / NCTEB017805
- Conditions
- Primary Immunodeficiency
- Keywords
- Primary Immunodeficiency, Subdermal bloodless space, Subdermal injection, Subcutaneous injection, Injectable electromyography needle, Electrical stimulation, MRI with Gadolinium
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- ASIS CorporationIndustry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 25 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
ASIS Corporation (ASIS) has developed the only automatic injection system for delivery of injectable products to it's optimum/right spot, just outside of the fascia, which exists subdermally (between the skin and muscle). Bloodless basically implies longer lasting medicinal effects, and minimal side effects - advantages that reflect the NIH mission of enhancing health, lengthening life, and reducing the burdens of illness and disability. ASIS device is stabilized on the surface of the skin with negative pressure and emits an electrical current to create a bloodless cavity subdermally. ASIS device correctly, automatically, and consistently delivers therapeutic agents, yet requiring little skill of a practitioner - providing the steady and safe infusion into subdermal bloodless space of virtually any injectable product in addition to Botox, including GAMMAGARD LIQUID, Enbrel, Insulin, and Fillers, etc. According to the FDA, "This innovation will have major impact on the healthcare industry."
Detailed description
Aim 1 would require 6 months, to demonstrate ASIS device's consistent performance on 60 subjects with Primary Immunodeficiency (PI), and the particular skin affected by this disease.
30 subjects will receive Gadolinium subcutaneously, and 30 subjects will receive Gadolinium subdermally with ASIS device. An MRI will be taken promptly after Gadolinium injection, as starting reference, to which subsequent MRI taken at 6 hrs, 12 hrs, and 24 hrs later will be compared for Persistent %. Since there isn't a way to measure level of Gadolinium within it, or any other (e.g.
GAMMAGARD) for that matter, at least the Prolongation of Gadolinium may be approximated by the greater or longer Persistent % on MRI. However, this approximation can only work if the variables are minimized to the same population with Primary Immunodeficiency (PI), and the particular skin affected by it. Case in point, Primary Immunodeficiency (PI) patients are prone to infection, and tend to have scared skin with less vascularity, so expectantly will have prolonged Gadolinium subcutaneously Persistent %, which will be very different from the skin of normal patients, while the Gadolinium subdermally Persistent % may or may not change. Therefore, the Relative Prolongation Ability Score or total Persistent % subdermally over that of total Persistent % subcutaneously, will be different and very specific for the particular skin affected by Primary Immunodeficiency. However, they are valuable indicators that will help us modify the GAMMAGARD dosage and duration to inject into that "unknown" subdermal space for Aim 2.
Aim 2 would require 12 months, using GAMMAGARD, instead of Gadolinium, to demonstrate the advantages of ASIS device subdermally over subcutaneously, for the same Primary Immunodeficiency subjects. Of course that Relative Prolongation Ability Score in Aim1 will be valuable, but it isn't absolutely required to start Aim 2, because GAMMAGARD's Pharmacokinetics will be studied anyway, by following Peak and Trough levels of immunoglobulin G.
However, the Pharmacokinetics of subdermally injected GAMMAGARD will be just dependent on GAMMAGARD's diffusion out of that subdermal bloodless space; therefore, if GAMMAGARD getting into the bloodstream becomes so severely inhibited, then we can just change the osmolality of GAMMAGARD in the end. The therapeutic advantages of GAMMAGARD with ASIS device subdermally over subcutaneously will also be studied by comparing the reduction of Validated Acute Serious Bacterial Infections, adverse reactions, and injection site pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 20
| Arm | Type | Receives |
|---|---|---|
| Gadolinium For abdomen | Experimental | Drug: Gadolinium For abdomen, Drug: Gadolinium For lower backGadolinium For abdomen Total Persistent % subdermally, For abdomen Total Persistent % subcutaneously, and For abdomen Relative Prolongation Ability Score. Gadolinium Magnevist® (gadopentetate dimeglumine) 1cc/ diluted with 19cc normal saline (for <40kg) or 29cc normal saline (for >40kg), subcutaneously for 30 patients, and subdermally with ASIS Device for 30 patients. |
| Gadolinium For lower back | Experimental | Drug: Gadolinium For abdomen, Drug: Gadolinium For lower back1cc/ diluted with 19cc normal saline (for <40kg) or 29cc normal saline (for >40kg), subcutaneously for 30 patients, and subdermally with ASIS Device for 30 patients. Gadolinium For lower back Total Persistent % subdermally, For lower back Total Persistent % subcutaneously, and For lower back Relative Prolongation Ability Score. |
| subjects (%) of any infections | Experimental | Drug: Efficacy of Gammagard subcutaneously at Week 12, Drug: Efficacy of Gammagard subcutaneously at Week 24, Drug: Efficacy of Gammagard subcutaneously at Week 36, Drug: Efficacy of Gammagard subdermally at Week 36, Drug: Efficacy of Gammagard subdermally at Week 12, Drug: Efficacy of Gammagard subdermally at Week 24subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 12, Efficacy of Gammagard subcutaneously at Week 24, and Efficacy of Gammagard subcutaneously at Week 36, vs. Efficacy of Gammagard subdermally at Week 12, Efficacy of Gammagard subdermally at Week 24, and Efficacy of Gammagard subdermally at Week 36. |
| Annual rate of any infections | Experimental | Drug: Efficacy of Gammagard subcutaneously at Week 12, Drug: Efficacy of Gammagard subcutaneously at Week 24, Drug: Efficacy of Gammagard subcutaneously at Week 36, Drug: Efficacy of Gammagard subdermally at Week 36, Drug: Efficacy of Gammagard subdermally at Week 12, Drug: Efficacy of Gammagard subdermally at Week 24Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 12, Efficacy of Gammagard subcutaneously at Week 24, and Efficacy of Gammagard subcutaneously at Week 36, vs. Efficacy of Gammagard subdermally at Week 12, Efficacy of Gammagard subdermally at Week 24, and Efficacy of Gammagard subdermally at Week 36. |
| subjects (%) with Antibiotic use | Experimental | Drug: Efficacy of Gammagard subcutaneously at Week 12, Drug: Efficacy of Gammagard subcutaneously at Week 24, Drug: Efficacy of Gammagard subcutaneously at Week 36, Drug: Efficacy of Gammagard subdermally at Week 36, Drug: Efficacy of Gammagard subdermally at Week 12, Drug: Efficacy of Gammagard subdermally at Week 24subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12, Efficacy of Gammagard subcutaneously at Week 24, and Efficacy of Gammagard subcutaneously at Week 36, vs. Efficacy of Gammagard subdermally at Week 12, Efficacy of Gammagard subdermally at Week 24, and Efficacy of Gammagard subdermally at Week 36. |
| Annual rate with Antibiotic use | Experimental | Drug: Efficacy of Gammagard subcutaneously at Week 12, Drug: Efficacy of Gammagard subcutaneously at Week 24, Drug: Efficacy of Gammagard subcutaneously at Week 36, Drug: Efficacy of Gammagard subdermally at Week 36, Drug: Efficacy of Gammagard subdermally at Week 12, Drug: Efficacy of Gammagard subdermally at Week 24Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12, Efficacy of Gammagard subcutaneously at Week 24, and Efficacy of Gammagard subcutaneously at Week 36, vs. Efficacy of Gammagard subdermally at Week 12, Efficacy of Gammagard subdermally at Week 24, and Efficacy of Gammagard subdermally at Week 36. |
| subjects (%) with Days out of work | Experimental | Drug: Efficacy of Gammagard subcutaneously at Week 12, Drug: Efficacy of Gammagard subcutaneously at Week 24, Drug: Efficacy of Gammagard subcutaneously at Week 36, Drug: Efficacy of Gammagard subdermally at Week 36, Drug: Efficacy of Gammagard subdermally at Week 12, Drug: Efficacy of Gammagard subdermally at Week 24subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 12, Efficacy of Gammagard subcutaneously at Week 24, and Efficacy of Gammagard subcutaneously at Week 36, vs. Efficacy of Gammagard subdermally at Week 12, Efficacy of Gammagard subdermally at Week 24, and Efficacy of Gammagard subdermally at Week 36. |
| Annual rate with Days out of work | Experimental | Drug: Efficacy of Gammagard subcutaneously at Week 12, Drug: Efficacy of Gammagard subcutaneously at Week 24, Drug: Efficacy of Gammagard subcutaneously at Week 36, Drug: Efficacy of Gammagard subdermally at Week 36, Drug: Efficacy of Gammagard subdermally at Week 12, Drug: Efficacy of Gammagard subdermally at Week 24Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 12, Efficacy of Gammagard subcutaneously at Week 24, and Efficacy of Gammagard subcutaneously at Week 36, vs. Efficacy of Gammagard subdermally at Week 12, Efficacy of Gammagard subdermally at Week 24, and Efficacy of Gammagard subdermally at Week 36. |
| (%) with hospitalized infections | Experimental | Drug: Efficacy of Gammagard subcutaneously at Week 12, Drug: Efficacy of Gammagard subcutaneously at Week 24, Drug: Efficacy of Gammagard subcutaneously at Week 36, Drug: Efficacy of Gammagard subdermally at Week 36, Drug: Efficacy of Gammagard subdermally at Week 12, Drug: Efficacy of Gammagard subdermally at Week 24(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12, Efficacy of Gammagard subcutaneously at Week 24, and Efficacy of Gammagard subcutaneously at Week 36, vs. Efficacy of Gammagard subdermally at Week 12, Efficacy of Gammagard subdermally at Week 24, and Efficacy of Gammagard subdermally at Week 36. |
| Annual rate hospitalized infections | Experimental | Drug: Efficacy of Gammagard subcutaneously at Week 12, Drug: Efficacy of Gammagard subcutaneously at Week 24, Drug: Efficacy of Gammagard subcutaneously at Week 36, Drug: Efficacy of Gammagard subdermally at Week 36, Drug: Efficacy of Gammagard subdermally at Week 12, Drug: Efficacy of Gammagard subdermally at Week 24Annual rate hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12, Efficacy of Gammagard subcutaneously at Week 24, and Efficacy of Gammagard subcutaneously at Week 36, vs. Efficacy of Gammagard subdermally at Week 12, Efficacy of Gammagard subdermally at Week 24, and Efficacy of Gammagard subdermally at Week 36. |
| Adverse Injection Local Reactions | Experimental | Drug: Adverse Reactions of Gammagard subcutaneously at Week 12, Drug: Adverse Reactions of Gammagard subcutaneously at Week 24, Drug: Adverse Reactions of Gammagard subcutaneously at Week 36, Drug: Adverse Reactions of Gammagard subdermally at Week 12, Drug: Adverse Reactions of Gammagard subdermally at Week 24, Drug: Adverse Reactions of Gammagard subdermally at Week 36Adverse Injection Local Reactions as Adverse Reactions of Gammagard subcutaneously at Week 12, Adverse Reactions of Gammagard subcutaneously at Week 24, and Adverse Reactions of Gammagard subcutaneously at Week 36, vs. Adverse Reactions of Gammagard subdermally at Week 12, Adverse Reactions of Gammagard subdermally at Week 24, and Adverse Reactions of Gammagard subdermally at Week 36. |
| Adverse Reactions Headache | Experimental | Drug: Adverse Reactions of Gammagard subcutaneously at Week 12, Drug: Adverse Reactions of Gammagard subcutaneously at Week 24, Drug: Adverse Reactions of Gammagard subcutaneously at Week 36, Drug: Adverse Reactions of Gammagard subdermally at Week 12, Drug: Adverse Reactions of Gammagard subdermally at Week 24, Drug: Adverse Reactions of Gammagard subdermally at Week 36Headache as Adverse Reactions of Gammagard subcutaneously at Week 12, Adverse Reactions of Gammagard subcutaneously at Week 24, and Adverse Reactions of Gammagard subcutaneously at Week 36, vs. Adverse Reactions of Gammagard subdermally at Week 12, Adverse Reactions of Gammagard subdermally at Week 24, and Adverse Reactions of Gammagard subdermally at Week 36. |
| Adverse Reactions Fever | Experimental | Drug: Adverse Reactions of Gammagard subcutaneously at Week 12, Drug: Adverse Reactions of Gammagard subcutaneously at Week 24, Drug: Adverse Reactions of Gammagard subcutaneously at Week 36, Drug: Adverse Reactions of Gammagard subdermally at Week 12, Drug: Adverse Reactions of Gammagard subdermally at Week 24, Drug: Adverse Reactions of Gammagard subdermally at Week 36Fever as Adverse Reactions of Gammagard subcutaneously at Week 12, Adverse Reactions of Gammagard subcutaneously at Week 24, and Adverse Reactions of Gammagard subcutaneously at Week 36, vs. Adverse Reactions of Gammagard subdermally at Week 12, Adverse Reactions of Gammagard subdermally at Week 24, and Adverse Reactions of Gammagard subdermally at Week 36. |
| Adverse Reactions Nausea | Experimental | Drug: Adverse Reactions of Gammagard subcutaneously at Week 12, Drug: Adverse Reactions of Gammagard subcutaneously at Week 24, Drug: Adverse Reactions of Gammagard subcutaneously at Week 36, Drug: Adverse Reactions of Gammagard subdermally at Week 12, Drug: Adverse Reactions of Gammagard subdermally at Week 24, Drug: Adverse Reactions of Gammagard subdermally at Week 36Nausea as Adverse Reactions of Gammagard subcutaneously at Week 12, Adverse Reactions of Gammagard subcutaneously at Week 24, and Adverse Reactions of Gammagard subcutaneously at Week 36, vs. Adverse Reactions of Gammagard subdermally at Week 12, Adverse Reactions of Gammagard subdermally at Week 24, and Adverse Reactions of Gammagard subdermally at Week 36. |
| Adverse Reactions Vomiting | Experimental | Drug: Adverse Reactions of Gammagard subcutaneously at Week 12, Drug: Adverse Reactions of Gammagard subcutaneously at Week 24, Drug: Adverse Reactions of Gammagard subcutaneously at Week 36, Drug: Adverse Reactions of Gammagard subdermally at Week 12, Drug: Adverse Reactions of Gammagard subdermally at Week 24, Drug: Adverse Reactions of Gammagard subdermally at Week 36Vomiting as Adverse Reactions of Gammagard subcutaneously at Week 12, Adverse Reactions of Gammagard subcutaneously at Week 24, and Adverse Reactions of Gammagard subcutaneously at Week 36, vs. Adverse Reactions of Gammagard subdermally at Week 12, Adverse Reactions of Gammagard subdermally at Week 24, and Adverse Reactions of Gammagard subdermally at Week 36. |
| Adverse Reactions Fatigue | Experimental | Drug: Adverse Reactions of Gammagard subcutaneously at Week 12, Drug: Adverse Reactions of Gammagard subcutaneously at Week 24, Drug: Adverse Reactions of Gammagard subcutaneously at Week 36, Drug: Adverse Reactions of Gammagard subdermally at Week 12, Drug: Adverse Reactions of Gammagard subdermally at Week 24, Drug: Adverse Reactions of Gammagard subdermally at Week 36Fatigue as Adverse Reactions of Gammagard subcutaneously at Week 12, Adverse Reactions of Gammagard subcutaneously at Week 24, and Adverse Reactions of Gammagard subcutaneously at Week 36, vs. Adverse Reactions of Gammagard subdermally at Week 12, Adverse Reactions of Gammagard subdermally at Week 24, and Adverse Reactions of Gammagard subdermally at Week 36. |
| Adverse Reactions Diarrhea | Experimental | Drug: Adverse Reactions of Gammagard subcutaneously at Week 12, Drug: Adverse Reactions of Gammagard subcutaneously at Week 24, Drug: Adverse Reactions of Gammagard subcutaneously at Week 36, Drug: Adverse Reactions of Gammagard subdermally at Week 12, Drug: Adverse Reactions of Gammagard subdermally at Week 24, Drug: Adverse Reactions of Gammagard subdermally at Week 36Diarrhea as Adverse Reactions of Gammagard subcutaneously at Week 12, Adverse Reactions of Gammagard subcutaneously at Week 24, and Adverse Reactions of Gammagard subcutaneously at Week 36, vs. Adverse Reactions of Gammagard subdermally at Week 12, Adverse Reactions of Gammagard subdermally at Week 24, and Adverse Reactions of Gammagard subdermally at Week 36. |
| Adverse Reactions Asthma | Experimental | Drug: Adverse Reactions of Gammagard subcutaneously at Week 12, Drug: Adverse Reactions of Gammagard subcutaneously at Week 24, Drug: Adverse Reactions of Gammagard subcutaneously at Week 36, Drug: Adverse Reactions of Gammagard subdermally at Week 12, Drug: Adverse Reactions of Gammagard subdermally at Week 24, Drug: Adverse Reactions of Gammagard subdermally at Week 36Asthma as Adverse Reactions of Gammagard subcutaneously at Week 12, Adverse Reactions of Gammagard subcutaneously at Week 24, and Adverse Reactions of Gammagard subcutaneously at Week 36, vs. Adverse Reactions of Gammagard subdermally at Week 12, Adverse Reactions of Gammagard subdermally at Week 24, and Adverse Reactions of Gammagard subdermally at Week 36. |
| Adverse Reactions Oropharyngeal | Experimental | Drug: Adverse Reactions of Gammagard subcutaneously at Week 12, Drug: Adverse Reactions of Gammagard subcutaneously at Week 24, Drug: Adverse Reactions of Gammagard subcutaneously at Week 36, Drug: Adverse Reactions of Gammagard subdermally at Week 12, Drug: Adverse Reactions of Gammagard subdermally at Week 24, Drug: Adverse Reactions of Gammagard subdermally at Week 36Oropharyngeal as Adverse Reactions of Gammagard subcutaneously at Week 12, Adverse Reactions of Gammagard subcutaneously at Week 24, and Adverse Reactions of Gammagard subcutaneously at Week 36, vs. Adverse Reactions of Gammagard subdermally at Week 12, Adverse Reactions of Gammagard subdermally at Week 24, and Adverse Reactions of Gammagard subdermally at Week 36. |
| Adverse Reactions Abdominal Pain | Experimental | Drug: Adverse Reactions of Gammagard subcutaneously at Week 12, Drug: Adverse Reactions of Gammagard subcutaneously at Week 24, Drug: Adverse Reactions of Gammagard subcutaneously at Week 36, Drug: Adverse Reactions of Gammagard subdermally at Week 12, Drug: Adverse Reactions of Gammagard subdermally at Week 24, Drug: Adverse Reactions of Gammagard subdermally at Week 36Abdominal Pain as Adverse Reactions of Gammagard subcutaneously at Week 12, Adverse Reactions of Gammagard subcutaneously at Week 24, and Adverse Reactions of Gammagard subcutaneously at Week 36, vs. Adverse Reactions of Gammagard subdermally at Week 12, Adverse Reactions of Gammagard subdermally at Week 24, and Adverse Reactions of Gammagard subdermally at Week 36. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Inclusion Criteria for Primary Immunodeficiency in particular:
Key exclusion criteria (2 listed)
- Exclusion Criteria for Primary Immunodeficiency in particular:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gadolinium For abdomenAlso: Gadolinium Magnevist® (gadopentetate dimeglumine)Gadolinium 1cc/ diluted with 19cc normal saline (for <40kg) or 29cc normal saline (for >40kg) subdermally with ASIS Device for 30 patients. Gadolinium For abdomen Total Persistent % subdermally on MRI at 6 hrs, 12 hrs, and 24 hrs. | Drug | Gadolinium For abdomen, Gadolinium For lower back |
| Gadolinium For abdomenAlso: Gadolinium Magnevist® (gadopentetate dimeglumine)Gadolinium 1cc/ diluted with 19cc normal saline (for <40kg) or 29cc normal saline (for >40kg) subcutaneously for 30 patients. Gadolinium For abdomen Total Persistent % subcutaneously on MRI at 6 hrs, 12 hrs, and 24 hrs. | Drug | Gadolinium For abdomen, Gadolinium For lower back |
| Gadolinium For abdomenAlso: Gadolinium Magnevist® (gadopentetate dimeglumine)Gadolinium For abdomen Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium subcutaneously on MRI. | Drug | Gadolinium For abdomen, Gadolinium For lower back |
| Gadolinium For lower backAlso: Gadolinium Magnevist® (gadopentetate dimeglumine)Gadolinium For lower back Total Persistent % subdermally on MRI at 6 hrs, 12 hrs, and 24 hrs. Gadolinium 1cc/ diluted with 19cc normal saline (for <40kg) or 29cc normal saline (for >40kg) subdermally with ASIS Device for 30 patients. | Drug | Gadolinium For abdomen, Gadolinium For lower back |
| Gadolinium For lower backAlso: Gadolinium Magnevist® (gadopentetate dimeglumine)Gadolinium For lower back Total cumulative Persistent % of Gadolinium subcutaneously on MRI at 6 hrs, 12 hrs, and 24 hrs. Gadolinium 1cc/ diluted with 19cc normal saline (for <40kg) or 29cc normal saline (for >40kg) subcutaneously for 30 patients. | Drug | Gadolinium For abdomen, Gadolinium For lower back |
| Gadolinium For lower backAlso: Gadolinium Magnevist® (gadopentetate dimeglumine)Gadolinium For lower back Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium subcutaneously on MRI . | Drug | Gadolinium For abdomen, Gadolinium For lower back |
| Efficacy of Gammagard subcutaneously at Week 12Also: Gammagard [Immune Globulin Infusion (Human)]subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 12. | Drug | (%) with hospitalized infections, Annual rate hospitalized infections, Annual rate of any infections, Annual rate with Antibiotic use, Annual rate with Days out of work, subjects (%) of any infections, subjects (%) with Antibiotic use, subjects (%) with Days out of work |
| Efficacy of Gammagard subcutaneously at Week 12Also: Gammagard [Immune Globulin Infusion (Human)]Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 12. | Drug | (%) with hospitalized infections, Annual rate hospitalized infections, Annual rate of any infections, Annual rate with Antibiotic use, Annual rate with Days out of work, subjects (%) of any infections, subjects (%) with Antibiotic use, subjects (%) with Days out of work |
| Efficacy of Gammagard subcutaneously at Week 12Also: Gammagard [Immune Globulin Infusion (Human)]subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12. | Drug | (%) with hospitalized infections, Annual rate hospitalized infections, Annual rate of any infections, Annual rate with Antibiotic use, Annual rate with Days out of work, subjects (%) of any infections, subjects (%) with Antibiotic use, subjects (%) with Days out of work |
| Efficacy of Gammagard subcutaneously at Week 12Also: Gammagard [Immune Globulin Infusion (Human)]Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12. | Drug | (%) with hospitalized infections, Annual rate hospitalized infections, Annual rate of any infections, Annual rate with Antibiotic use, Annual rate with Days out of work, subjects (%) of any infections, subjects (%) with Antibiotic use, subjects (%) with Days out of work |
| Efficacy of Gammagard subcutaneously at Week 12Also: Gammagard [Immune Globulin Infusion (Human)]subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 12. | Drug | (%) with hospitalized infections, Annual rate hospitalized infections, Annual rate of any infections, Annual rate with Antibiotic use, Annual rate with Days out of work, subjects (%) of any infections, subjects (%) with Antibiotic use, subjects (%) with Days out of work |
| Efficacy of Gammagard subcutaneously at Week 12Also: Gammagard [Immune Globulin Infusion (Human)]Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 12. | Drug | (%) with hospitalized infections, Annual rate hospitalized infections, Annual rate of any infections, Annual rate with Antibiotic use, Annual rate with Days out of work, subjects (%) of any infections, subjects (%) with Antibiotic use, subjects (%) with Days out of work |
| Efficacy of Gammagard subcutaneously at Week 12Also: Gammagard [Immune Globulin Infusion (Human)](%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12. | Drug | (%) with hospitalized infections, Annual rate hospitalized infections, Annual rate of any infections, Annual rate with Antibiotic use, Annual rate with Days out of work, subjects (%) of any infections, subjects (%) with Antibiotic use, subjects (%) with Days out of work |
| Efficacy of Gammagard subcutaneously at Week 12Also: Gammagard [Immune Globulin Infusion (Human)]Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12. | Drug | (%) with hospitalized infections, Annual rate hospitalized infections, Annual rate of any infections, Annual rate with Antibiotic use, Annual rate with Days out of work, subjects (%) of any infections, subjects (%) with Antibiotic use, subjects (%) with Days out of work |
| Efficacy of Gammagard subcutaneously at Week 24Also: Gammagard [Immune Globulin Infusion (Human)]subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 24. | Drug | (%) with hospitalized infections, Annual rate hospitalized infections, Annual rate of any infections, Annual rate with Antibiotic use, Annual rate with Days out of work, subjects (%) of any infections, subjects (%) with Antibiotic use, subjects (%) with Days out of work |
| Efficacy of Gammagard subcutaneously at Week 24Also: Gammagard [Immune Globulin Infusion (Human)]Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 24. | Drug | (%) with hospitalized infections, Annual rate hospitalized infections, Annual rate of any infections, Annual rate with Antibiotic use, Annual rate with Days out of work, subjects (%) of any infections, subjects (%) with Antibiotic use, subjects (%) with Days out of work |
| Efficacy of Gammagard subcutaneously at Week 24Also: Gammagard [Immune Globulin Infusion (Human)]subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 24. | Drug | (%) with hospitalized infections, Annual rate hospitalized infections, Annual rate of any infections, Annual rate with Antibiotic use, Annual rate with Days out of work, subjects (%) of any infections, subjects (%) with Antibiotic use, subjects (%) with Days out of work |
| Efficacy of Gammagard subcutaneously at Week 24Also: Gammagard [Immune Globulin Infusion (Human)]Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 24. | Drug | (%) with hospitalized infections, Annual rate hospitalized infections, Annual rate of any infections, Annual rate with Antibiotic use, Annual rate with Days out of work, subjects (%) of any infections, subjects (%) with Antibiotic use, subjects (%) with Days out of work |
| Efficacy of Gammagard subcutaneously at Week 24Also: Gammagard [Immune Globulin Infusion (Human)]subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 24. | Drug | (%) with hospitalized infections, Annual rate hospitalized infections, Annual rate of any infections, Annual rate with Antibiotic use, Annual rate with Days out of work, subjects (%) of any infections, subjects (%) with Antibiotic use, subjects (%) with Days out of work |
| Efficacy of Gammagard subcutaneously at Week 24Also: Gammagard [Immune Globulin Infusion (Human)]Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 24 | Drug | (%) with hospitalized infections, Annual rate hospitalized infections, Annual rate of any infections, Annual rate with Antibiotic use, Annual rate with Days out of work, subjects (%) of any infections, subjects (%) with Antibiotic use, subjects (%) with Days out of work |
| Efficacy of Gammagard subcutaneously at Week 24Also: Gammagard [Immune Globulin Infusion (Human)](%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 24. | Drug | (%) with hospitalized infections, Annual rate hospitalized infections, Annual rate of any infections, Annual rate with Antibiotic use, Annual rate with Days out of work, subjects (%) of any infections, subjects (%) with Antibiotic use, subjects (%) with Days out of work |
| Efficacy of Gammagard subcutaneously at Week 24Also: Gammagard [Immune Globulin Infusion (Human)]Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 24. | Drug | (%) with hospitalized infections, Annual rate hospitalized infections, Annual rate of any infections, Annual rate with Antibiotic use, Annual rate with Days out of work, subjects (%) of any infections, subjects (%) with Antibiotic use, subjects (%) with Days out of work |
| Efficacy of Gammagard subcutaneously at Week 36Also: Gammagard [Immune Globulin Infusion (Human)]subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 36. | Drug | (%) with hospitalized infections, Annual rate hospitalized infections, Annual rate of any infections, Annual rate with Antibiotic use, Annual rate with Days out of work, subjects (%) of any infections, subjects (%) with Antibiotic use, subjects (%) with Days out of work |
| Efficacy of Gammagard subcutaneously at Week 36Also: Gammagard [Immune Globulin Infusion (Human)]Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 36. | Drug | (%) with hospitalized infections, Annual rate hospitalized infections, Annual rate of any infections, Annual rate with Antibiotic use, Annual rate with Days out of work, subjects (%) of any infections, subjects (%) with Antibiotic use, subjects (%) with Days out of work |
| Efficacy of Gammagard subcutaneously at Week 36Also: Gammagard [Immune Globulin Infusion (Human)]subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 36. | Drug | (%) with hospitalized infections, Annual rate hospitalized infections, Annual rate of any infections, Annual rate with Antibiotic use, Annual rate with Days out of work, subjects (%) of any infections, subjects (%) with Antibiotic use, subjects (%) with Days out of work |
| Efficacy of Gammagard subcutaneously at Week 36Also: Gammagard [Immune Globulin Infusion (Human)]Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 36. | Drug | (%) with hospitalized infections, Annual rate hospitalized infections, Annual rate of any infections, Annual rate with Antibiotic use, Annual rate with Days out of work, subjects (%) of any infections, subjects (%) with Antibiotic use, subjects (%) with Days out of work |
| Efficacy of Gammagard subcutaneously at Week 36Also: Gammagard [Immune Globulin Infusion (Human)]subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 36. | Drug | (%) with hospitalized infections, Annual rate hospitalized infections, Annual rate of any infections, Annual rate with Antibiotic use, Annual rate with Days out of work, subjects (%) of any infections, subjects (%) with Antibiotic use, subjects (%) with Days out of work |
| Efficacy of Gammagard subdermally at Week 36Also: Gammagard [Immune Globulin Infusion (Human)]Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 36. | Drug | (%) with hospitalized infections, Annual rate hospitalized infections, Annual rate of any infections, Annual rate with Antibiotic use, Annual rate with Days out of work, subjects (%) of any infections, subjects (%) with Antibiotic use, subjects (%) with Days out of work |
| Efficacy of Gammagard subdermally at Week 36Also: Gammagard [Immune Globulin Infusion (Human)](%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 36. | Drug | (%) with hospitalized infections, Annual rate hospitalized infections, Annual rate of any infections, Annual rate with Antibiotic use, Annual rate with Days out of work, subjects (%) of any infections, subjects (%) with Antibiotic use, subjects (%) with Days out of work |
| Efficacy of Gammagard subdermally at Week 36Also: Gammagard [Immune Globulin Infusion (Human)]Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 36. | Drug | (%) with hospitalized infections, Annual rate hospitalized infections, Annual rate of any infections, Annual rate with Antibiotic use, Annual rate with Days out of work, subjects (%) of any infections, subjects (%) with Antibiotic use, subjects (%) with Days out of work |
| Efficacy of Gammagard subdermally at Week 12Also: Gammagard [Immune Globulin Infusion (Human)]subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 12 | Drug | (%) with hospitalized infections, Annual rate hospitalized infections, Annual rate of any infections, Annual rate with Antibiotic use, Annual rate with Days out of work, subjects (%) of any infections, subjects (%) with Antibiotic use, subjects (%) with Days out of work |
| Efficacy of Gammagard subdermally at Week 12Also: Gammagard [Immune Globulin Infusion (Human)]Annual rate of any infections as Efficacy of Gammagard subdermally at Week 12 | Drug | (%) with hospitalized infections, Annual rate hospitalized infections, Annual rate of any infections, Annual rate with Antibiotic use, Annual rate with Days out of work, subjects (%) of any infections, subjects (%) with Antibiotic use, subjects (%) with Days out of work |
| Efficacy of Gammagard subdermally at Week 12Also: Gammagard [Immune Globulin Infusion (Human)]subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 12 | Drug | (%) with hospitalized infections, Annual rate hospitalized infections, Annual rate of any infections, Annual rate with Antibiotic use, Annual rate with Days out of work, subjects (%) of any infections, subjects (%) with Antibiotic use, subjects (%) with Days out of work |
| Efficacy of Gammagard subdermally at Week 12Also: Gammagard [Immune Globulin Infusion (Human)]Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 12 | Drug | (%) with hospitalized infections, Annual rate hospitalized infections, Annual rate of any infections, Annual rate with Antibiotic use, Annual rate with Days out of work, subjects (%) of any infections, subjects (%) with Antibiotic use, subjects (%) with Days out of work |
| Efficacy of Gammagard subdermally at Week 12Also: Gammagard [Immune Globulin Infusion (Human)]subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 12 | Drug | (%) with hospitalized infections, Annual rate hospitalized infections, Annual rate of any infections, Annual rate with Antibiotic use, Annual rate with Days out of work, subjects (%) of any infections, subjects (%) with Antibiotic use, subjects (%) with Days out of work |
| Efficacy of Gammagard subdermally at Week 12Also: Gammagard [Immune Globulin Infusion (Human)]Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 12 | Drug | (%) with hospitalized infections, Annual rate hospitalized infections, Annual rate of any infections, Annual rate with Antibiotic use, Annual rate with Days out of work, subjects (%) of any infections, subjects (%) with Antibiotic use, subjects (%) with Days out of work |
| Efficacy of Gammagard subdermally at Week 12Also: Gammagard [Immune Globulin Infusion (Human)](%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 12 | Drug | (%) with hospitalized infections, Annual rate hospitalized infections, Annual rate of any infections, Annual rate with Antibiotic use, Annual rate with Days out of work, subjects (%) of any infections, subjects (%) with Antibiotic use, subjects (%) with Days out of work |
| Efficacy of Gammagard subdermally at Week 12Also: Gammagard [Immune Globulin Infusion (Human)]Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 12. | Drug | (%) with hospitalized infections, Annual rate hospitalized infections, Annual rate of any infections, Annual rate with Antibiotic use, Annual rate with Days out of work, subjects (%) of any infections, subjects (%) with Antibiotic use, subjects (%) with Days out of work |
| Efficacy of Gammagard subdermally at Week 24Also: Gammagard [Immune Globulin Infusion (Human)]subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 24. | Drug | (%) with hospitalized infections, Annual rate hospitalized infections, Annual rate of any infections, Annual rate with Antibiotic use, Annual rate with Days out of work, subjects (%) of any infections, subjects (%) with Antibiotic use, subjects (%) with Days out of work |
| Efficacy of Gammagard subdermally at Week 24Also: Gammagard [Immune Globulin Infusion (Human)]Annual rate of any infections as Efficacy of Gammagard subdermally at Week 24. | Drug | (%) with hospitalized infections, Annual rate hospitalized infections, Annual rate of any infections, Annual rate with Antibiotic use, Annual rate with Days out of work, subjects (%) of any infections, subjects (%) with Antibiotic use, subjects (%) with Days out of work |
| Efficacy of Gammagard subdermally at Week 24Also: Gammagard [Immune Globulin Infusion (Human)]subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 24. | Drug | (%) with hospitalized infections, Annual rate hospitalized infections, Annual rate of any infections, Annual rate with Antibiotic use, Annual rate with Days out of work, subjects (%) of any infections, subjects (%) with Antibiotic use, subjects (%) with Days out of work |
| Efficacy of Gammagard subdermally at Week 24Also: Gammagard [Immune Globulin Infusion (Human)]Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 24. | Drug | (%) with hospitalized infections, Annual rate hospitalized infections, Annual rate of any infections, Annual rate with Antibiotic use, Annual rate with Days out of work, subjects (%) of any infections, subjects (%) with Antibiotic use, subjects (%) with Days out of work |
| Efficacy of Gammagard subdermally at Week 24Also: Gammagard [Immune Globulin Infusion (Human)]subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 24. | Drug | (%) with hospitalized infections, Annual rate hospitalized infections, Annual rate of any infections, Annual rate with Antibiotic use, Annual rate with Days out of work, subjects (%) of any infections, subjects (%) with Antibiotic use, subjects (%) with Days out of work |
| Efficacy of Gammagard subdermally at Week 24Also: Gammagard [Immune Globulin Infusion (Human)]Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 24. | Drug | (%) with hospitalized infections, Annual rate hospitalized infections, Annual rate of any infections, Annual rate with Antibiotic use, Annual rate with Days out of work, subjects (%) of any infections, subjects (%) with Antibiotic use, subjects (%) with Days out of work |
| Efficacy of Gammagard subdermally at Week 24Also: Gammagard [Immune Globulin Infusion (Human)](%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 24. | Drug | (%) with hospitalized infections, Annual rate hospitalized infections, Annual rate of any infections, Annual rate with Antibiotic use, Annual rate with Days out of work, subjects (%) of any infections, subjects (%) with Antibiotic use, subjects (%) with Days out of work |
| Efficacy of Gammagard subdermally at Week 24Also: Gammagard [Immune Globulin Infusion (Human)]Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 24. | Drug | (%) with hospitalized infections, Annual rate hospitalized infections, Annual rate of any infections, Annual rate with Antibiotic use, Annual rate with Days out of work, subjects (%) of any infections, subjects (%) with Antibiotic use, subjects (%) with Days out of work |
| Efficacy of Gammagard subdermally at Week 36Also: Gammagard [Immune Globulin Infusion (Human)]subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 36. | Drug | (%) with hospitalized infections, Annual rate hospitalized infections, Annual rate of any infections, Annual rate with Antibiotic use, Annual rate with Days out of work, subjects (%) of any infections, subjects (%) with Antibiotic use, subjects (%) with Days out of work |
| Efficacy of Gammagard subdermally at Week 36Also: Gammagard [Immune Globulin Infusion (Human)]Annual rate of any infections as Efficacy of Gammagard subdermally at Week 36. | Drug | (%) with hospitalized infections, Annual rate hospitalized infections, Annual rate of any infections, Annual rate with Antibiotic use, Annual rate with Days out of work, subjects (%) of any infections, subjects (%) with Antibiotic use, subjects (%) with Days out of work |
| Efficacy of Gammagard subdermally at Week 36Also: Gammagard [Immune Globulin Infusion (Human)]subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 36. | Drug | (%) with hospitalized infections, Annual rate hospitalized infections, Annual rate of any infections, Annual rate with Antibiotic use, Annual rate with Days out of work, subjects (%) of any infections, subjects (%) with Antibiotic use, subjects (%) with Days out of work |
| Efficacy of Gammagard subdermally at Week 36Also: Gammagard [Immune Globulin Infusion (Human)]Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 36. | Drug | (%) with hospitalized infections, Annual rate hospitalized infections, Annual rate of any infections, Annual rate with Antibiotic use, Annual rate with Days out of work, subjects (%) of any infections, subjects (%) with Antibiotic use, subjects (%) with Days out of work |
| Efficacy of Gammagard subdermally at Week 36Also: Gammagard [Immune Globulin Infusion (Human)]subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 36. | Drug | (%) with hospitalized infections, Annual rate hospitalized infections, Annual rate of any infections, Annual rate with Antibiotic use, Annual rate with Days out of work, subjects (%) of any infections, subjects (%) with Antibiotic use, subjects (%) with Days out of work |
| Efficacy of Gammagard subdermally at Week 36Also: Gammagard [Immune Globulin Infusion (Human)]Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 36. | Drug | (%) with hospitalized infections, Annual rate hospitalized infections, Annual rate of any infections, Annual rate with Antibiotic use, Annual rate with Days out of work, subjects (%) of any infections, subjects (%) with Antibiotic use, subjects (%) with Days out of work |
| Efficacy of Gammagard subdermally at Week 36Also: Gammagard [Immune Globulin Infusion (Human)](%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 36. | Drug | (%) with hospitalized infections, Annual rate hospitalized infections, Annual rate of any infections, Annual rate with Antibiotic use, Annual rate with Days out of work, subjects (%) of any infections, subjects (%) with Antibiotic use, subjects (%) with Days out of work |
| Efficacy of Gammagard subdermally at Week 36Also: Gammagard [Immune Globulin Infusion (Human)]Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 36. | Drug | (%) with hospitalized infections, Annual rate hospitalized infections, Annual rate of any infections, Annual rate with Antibiotic use, Annual rate with Days out of work, subjects (%) of any infections, subjects (%) with Antibiotic use, subjects (%) with Days out of work |
| Adverse Reactions of Gammagard subcutaneously at Week 12Also: Gammagard [Immune Globulin Infusion (Human)]Adverse Reactions of Gammagard subcutaneously at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain. | Drug | Adverse Injection Local Reactions, Adverse Reactions Abdominal Pain, Adverse Reactions Asthma, Adverse Reactions Diarrhea, Adverse Reactions Fatigue, Adverse Reactions Fever, Adverse Reactions Headache, Adverse Reactions Nausea, Adverse Reactions Oropharyngeal, Adverse Reactions Vomiting |
| Adverse Reactions of Gammagard subcutaneously at Week 24Also: Gammagard [Immune Globulin Infusion (Human)]Adverse Reactions of Gammagard subcutaneously at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain. | Drug | Adverse Injection Local Reactions, Adverse Reactions Abdominal Pain, Adverse Reactions Asthma, Adverse Reactions Diarrhea, Adverse Reactions Fatigue, Adverse Reactions Fever, Adverse Reactions Headache, Adverse Reactions Nausea, Adverse Reactions Oropharyngeal, Adverse Reactions Vomiting |
| Adverse Reactions of Gammagard subcutaneously at Week 36Also: Gammagard [Immune Globulin Infusion (Human)]Adverse Reactions of Gammagard subcutaneously at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain. | Drug | Adverse Injection Local Reactions, Adverse Reactions Abdominal Pain, Adverse Reactions Asthma, Adverse Reactions Diarrhea, Adverse Reactions Fatigue, Adverse Reactions Fever, Adverse Reactions Headache, Adverse Reactions Nausea, Adverse Reactions Oropharyngeal, Adverse Reactions Vomiting |
| Adverse Reactions of Gammagard subdermally at Week 12Also: Gammagard [Immune Globulin Infusion (Human)]Adverse Reactions of Gammagard subdermally at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain | Drug | Adverse Injection Local Reactions, Adverse Reactions Abdominal Pain, Adverse Reactions Asthma, Adverse Reactions Diarrhea, Adverse Reactions Fatigue, Adverse Reactions Fever, Adverse Reactions Headache, Adverse Reactions Nausea, Adverse Reactions Oropharyngeal, Adverse Reactions Vomiting |
| Adverse Reactions of Gammagard subdermally at Week 24Also: Gammagard [Immune Globulin Infusion (Human)]Adverse Reactions of Gammagard subdermally at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain. | Drug | Adverse Injection Local Reactions, Adverse Reactions Abdominal Pain, Adverse Reactions Asthma, Adverse Reactions Diarrhea, Adverse Reactions Fatigue, Adverse Reactions Fever, Adverse Reactions Headache, Adverse Reactions Nausea, Adverse Reactions Oropharyngeal, Adverse Reactions Vomiting |
| Adverse Reactions of Gammagard subdermally at Week 36Also: Gammagard [Immune Globulin Infusion (Human)]Adverse Reactions of Gammagard subdermally at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain. | Drug | Adverse Injection Local Reactions, Adverse Reactions Abdominal Pain, Adverse Reactions Asthma, Adverse Reactions Diarrhea, Adverse Reactions Fatigue, Adverse Reactions Fever, Adverse Reactions Headache, Adverse Reactions Nausea, Adverse Reactions Oropharyngeal, Adverse Reactions Vomiting |
Primary outcome
Relative Prolongation Ability Score for Gadolinium subdermally injected
Time frame: 6 months
Gadolinium will be injected with ASIS subdermally (30) or conventional subcutaneous (30) for 60 adult subjects with Primary Immunodeficiency. The first MRI taken promptly after Gadolinium injection for each patient would be his or her reference of 100% Persistent, to which his or her subsequent MRI taken @ 6 hr, @ 12 hr, and @24hr later will be compared for Persistent %. This approximation can only work if the variables are minimized to the same population with Primary Immunodeficiency. The Relative Prolongation Ability Score or total Persistent % subdermally over total Persistent % subcutaneously, in Primary Immunodeficiency will be very valuable indicators for us to modify the GAMMAGARD dosage and duration for testing with that "unknown" subdermal bloodless space in Aim 2.
1 secondary outcome
Efficacy of GAMMAGARD subcutaneously vs. subdermally in Primary Immunodeficiency
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2015.
- Background: PubMed 980495Paonessa DF, Goldstein JC. Anatomy and physiology of head and neck infections (with emphasis on the fascia of the face and neck). Otolaryngol Clin North Am. 1976 Oct;9(3):561-80. No abstract available.
- BackgroundMagnevist (gadopentetate dimeglumine) Injection Product Information: http://pharma.bayer.com/scripts/pages/en/products/diagnostic_imaging/index.php
- BackgroundBotox (onabotulinumtoxinA) Product Information: http://www.botoxcosmetic.com/botox_physician_info/Clinical_Information.aspx http://www.clinicaltrials.gov/ct2/show/NCT01313767?term=Botox+pi&rank=1
- BackgroundGAMMAGARD LIQUID Comparison of Intravenous and Subcutaneous Administration in Primary Immunodeficiency Diseases (PID): http://www.clinicaltrials.gov/ct2/show/NCT00546871?term=Gammagard+subcutaneous&rank=5
- Background: PubMed 18466176Daw Z, Padmore R, Neurath D, Cober N, Tokessy M, Desjardins D, Olberg B, Tinmouth A, Giulivi A. Hemolytic transfusion reactions after administration of intravenous immune (gamma) globulin: a case series analysis. Transfusion. 2008 Aug;48(8):1598-601. doi: 10.1111/j.1537-2995.2008.01721.x. Epub 2008 May 2.
- Background: PubMed 17902731Mignogna MD, Fortuna G, Ruoppo E, Adamo D, Leuci S, Fedele S. Variations in serum hemoglobin, albumin, and electrolytes in patients receiving intravenous immunoglobulin therapy: a real clinical threat? Am J Clin Dermatol. 2007;8(5):291-9. doi: 10.2165/00128071-200708050-00004.
- Background: PubMed 12869106Kreil TR, Berting A, Kistner O, Kindermann J. West Nile virus and the safety of plasma derivatives: verification of high safety margins, and the validity of predictions based on model virus data. Transfusion. 2003 Aug;43(8):1023-8. doi: 10.1046/j.1537-2995.2003.00496.x.
- Background: PubMed 16783465Ochs HD, Gupta S, Kiessling P, Nicolay U, Berger M; Subcutaneous IgG Study Group. Safety and efficacy of self-administered subcutaneous immunoglobulin in patients with primary immunodeficiency diseases. J Clin Immunol. 2006 May;26(3):265-73. doi: 10.1007/s10875-006-9021-7.
- Background: PubMed 16758340Gardulf A, Nicolay U, Asensio O, Bernatowska E, Bock A, Carvalho BC, Granert C, Haag S, Hernandez D, Kiessling P, Kus J, Pons J, Niehues T, Schmidt S, Schulze I, Borte M. Rapid subcutaneous IgG replacement therapy is effective and safe in children and adults with primary immunodeficiencies--a prospective, multi-national study. J Clin Immunol. 2006 Mar;26(2):177-85. doi: 10.1007/s10875-006-9002-x. Epub 2006 Apr 26.
- Background: PubMed 16580469Orange JS, Hossny EM, Weiler CR, Ballow M, Berger M, Bonilla FA, Buckley R, Chinen J, El-Gamal Y, Mazer BD, Nelson RP Jr, Patel DD, Secord E, Sorensen RU, Wasserman RL, Cunningham-Rundles C; Primary Immunodeficiency Committee of the American Academy of Allergy, Asthma and Immunology. Use of intravenous immunoglobulin in human disease: a review of evidence by members of the Primary Immunodeficiency Committee of the American Academy of Allergy, Asthma and Immunology. J Allergy Clin Immunol. 2006 Apr;117(4 Suppl):S525-53. doi: 10.1016/j.jaci.2006.01.015.
- Background: PubMed 15945566Bonilla FA, Bernstein IL, Khan DA, Ballas ZK, Chinen J, Frank MM, Kobrynski LJ, Levinson AI, Mazer B, Nelson RP Jr, Orange JS, Routes JM, Shearer WT, Sorensen RU; American Academy of Allergy, Asthma and Immunology; American College of Allergy, Asthma and Immunology; Joint Council of Allergy, Asthma and Immunology. Practice parameter for the diagnosis and management of primary immunodeficiency. Ann Allergy Asthma Immunol. 2005 May;94(5 Suppl 1):S1-63. doi: 10.1016/s1081-1206(10)61142-8. No abstract available.
- Background: PubMed 19833910Kahwaji J, Barker E, Pepkowitz S, Klapper E, Villicana R, Peng A, Chang R, Jordan SC, Vo AA. Acute hemolysis after high-dose intravenous immunoglobulin therapy in highly HLA sensitized patients. Clin J Am Soc Nephrol. 2009 Dec;4(12):1993-7. doi: 10.2215/CJN.04540709. Epub 2009 Oct 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Nguyen, MD principal investigator
AUTOMATIC SUBDERMAL INJECTOR SYSTEM INC
Thanh Phung, MD principal investigator
AUTOMATIC SUBDERMAL INJECTOR SYSTEM, INC
Hanh Nguyen, MD principal investigator
AUTOMATIC SUBDERMAL INJECTOR SYSTEM,INC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Gadolinium For abdomen, Gadolinium For lower back and Efficacy of Gammagard subcutaneously at Week 12 in people with Primary Immunodeficiency, run by ASIS Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Nguyen, MD ((714)-453-7857, dr.li.nguyen@asis-inc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative Prolongation Ability Score for Gadolinium subdermally injected (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02123615, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2015.