Primary ImmunodeficiencyPhase 3NCT03814798
Study Evaluating IGSC 20% Flexible Dosing in Treatment-Experienced and Treatment-Naive Subjects With Primary Immunodeficiency
A Phase 3 study testing IGSC 20% daily push versus every 2 weeks pump, IGSC 20% daily push versus once a week pump and IGSC 20% daily push versus 2 times per week pump in people with Primary Immunodeficiency, run by Grifols Therapeutics LLC at 4 sites in United States.
Trial summary
This is a prospective, multi-center, randomized, open-label, 2-period cross-over study (16 weeks per treatment period) to evaluate flexible dosing and daily push dosing of IGSC 20% in treatment-experienced subjects with PI. Read more about this study
- Who is it for?
- Ages 2 to 75 years
- Conditions the study is for
- Primary Immunodeficiency
- What is being tested?
- IGSC 20% daily push versus every 2 weeks pump, IGSC 20% daily push versus once a week pump and IGSC 20% daily push versus 2 times per week pump
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 4 sitesUnited States
- Study dates
- Dec 2019to Sep 2020
- Phase
- Phase 3
- 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 2 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- For treatment-experienced subjects:
- Has documented and confirmed pre-existing diagnosis of PI with features of hypogammaglobulinemia requiring IgG replacement therapy including but not limited to the following humoral-based immunodeficiency syndromes (eg, X-linked agammaglobulinemia, common variable immunodeficiency), and combined immunodeficiency syndromes without lymphocytopenia (eg, hyper immunoglobulin M immunodeficiency syndrome).
- Has not had a SBI or been hospitalized for infection of any etiology (eg, viral, fungal, parasitic) within the last 3 months prior to screening or during screening.
- Is currently receiving IgG replacement therapy for ≥3 months via IV or SC infusion. Subjects receiving IVIG prior to study must receive a dosage of at least 200 mg/kg per infusion
- Has Screening IgG trough levels ≥500 mg/dL. Note: If screening trough levels are not above this threshold, the subjects will be considered a screen failure, but may be rescreened following dose adjustment of their original IgG replacement therapy regimen and maintaining stable dosing for a period of at least 3 months prior to screening a second time.
- Has signed an informed consent. Note: The subject must sign the informed consent form (ICF) if at least 18 years old; for children of younger age, the subject's parent or legal guardian must sign the ICF and if appropriate/applicable, the subject must sign a Child Assent form approved by the IRB/EC per the institution's requirements
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- For treatment-naïve subjects:
- Has documented and confirmed diagnosis of PI with features of hypogammaglobulinemia requiring IgG replacement therapy including but not limited to the following humoral-based immunodeficiency syndromes (eg, X-linked agammaglobulinemia, common variable immunodeficiency), and combined immunodeficiency syndromes without lymphocytopenia (eg, hyper immunoglobulin M immunodeficiency syndrome).
- Has never received IgG replacement treatment (ie, no prior immune globulin replacement therapy)
- Has Screening IgG level ≤400 mg/dL
- Does not have an SBI nor requires hospitalization for infection of any etiology (eg, viral, fungal, parasitic) during screening or at baseline.
- Has signed an informed consent. Note: The subject must sign the informed consent form (ICF) if at least 18 years old; for children of younger age, the subject's parent or legal guardian must sign the ICF and if appropriate/applicable, the subject must sign a Child Assent form approved by the IRB/EC per the institution's requirements
Who cannot join
- For all subjects:
- Has clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may interfere with successful completion of the trial or place the subject at undue medical risk.
- Has had a known serious adverse reaction to immunoglobulin or any anaphylactic reaction to blood or any blood-derived product
- Has a history of blistering skin disease, clinically significant thrombocytopenia, bleeding disorder, diffuse rash, recurrent skin infections, or other disorders where SC therapy would be contraindicated during the study.
- Has known isolated IgG subclass deficiency; isolated specific antibody deficiency (SAD) or selective IgG deficiency; or transient hypogammaglobulinemia of infancy. Note: Subjects are not to be enrolled if their primary PI diagnosis does not entail an actual quantitative deficit in total IgG. For example, SAD is defined as an impaired specific IgG response to pneumococcal vaccine with normal serum concentrations of IgG, IgM, and IgA. Isolated IgG subclass deficiency is defined as an abnormally low level of 1 or more IgG subclass in subjects with normal levels of total IgG and IgM.
- Has known selective IgA deficiency (with or without antibodies to IgA) (Note: exclusion is for the specific diagnostic entity. It does not exclude other forms of humoral primary immunodeficiency which have decreased IgA in addition to decreased IgG requiring IgG replacement).
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- Is female of childbearing potential who is pregnant, has a positive pregnancy test at screening (serum human chorionic gonadotropin [HCG]- based assay), is breastfeeding, or is unwilling to practice a highly effective method of contraception (oral, injectable or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, condom or occlusive cap with spermicidal foam/gel/film/cream/suppository, male sterilization, or true abstinence) throughout the study. Note: True abstinence: When this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods], declaration of abstinence for the duration of a trial, and withdrawal are not acceptable methods of contraception.)
- Has significant proteinuria (≥3+ or known urinary protein loss >1 g/24 hours or nephrotic syndrome), has acute renal failure, is on dialysis, and/or has severe renal impairment on Screening laboratory testing (blood urea nitrogen or creatinine more than 2.5 times the upper limit of normal [ULN]).
- Has screening values of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels exceeding more than 2.5 times the ULN for the expected normal range for the testing laboratory.
- Has hemoglobin <9 g/dL at screening.
- Has a history (either 1 episode within the year prior to the Screening Visit or 2 previous episodes over a lifetime) of or current diagnosis of thromboembolism (eg, myocardial infarction, cerebrovascular accident or transient ischemic attack) or deep venous thrombosis.
- Is currently receiving anti-coagulation therapy which would make SC administration inadvisable (vitamin K antagonists, nonvitamin K antagonist oral anticoagulants [eg, dabigatran etexilate targeting Factor IIa, rivaroxaban, edoxaban, and apixaban targeting Factor Xa], and parenteral anticoagulants [eg, fondaparinux]).
- Currently has a known hyperviscosity syndrome.
- Has an acquired medical condition that is known to cause secondary immune deficiency, such as chronic lymphocytic leukemia, lymphoma, multiple myeloma, chronic or recurrent neutropenia (absolute neutrophil count less than 1000/μL [1.0 x 10^9/L]), or human immunodeficiency virus infection/acquired immune deficiency syndrome.
- Has a known previous infection with or clinical signs and symptoms consistent with current hepatitis B virus or hepatitis C virus infection.
- If <18 years of age, has non-controlled arterial hypertension at a level of greater than or equal to the 90th percentile blood pressure (either systolic or diastolic) for their age and height or the adult subject has non- controlled arterial hypertension (systolic blood pressure [SBP] >160 mmHg and/or diastolic blood pressure [DBP] >100 mmHg).
- Is receiving any of the following medications:
- immunosuppressants including chemotherapeutic agents;
- immunomodulators; (c) long-term systemic corticosteroids defined as daily dose >1 mg of prednisone equivalent/kg/day for >30 days. Note: Intermittent courses of corticosteroids of not more than 10 days would not exclude a subject. Inhaled or topical corticosteroids are allowed.
- Has known substance or prescription drug abuse.
- Has participated in another clinical trial within 30 days prior to screening (observational studies without investigative treatments [non- interventional] are permitted) or has received any investigational blood product with the exception of other IgG products within the previous 3 months.
- Is a subject/caregiver unwilling to comply with any aspect of the protocol, including home SC infusions, blood sampling, and completion of a SC infusion diary for the duration of the study.
- Is a mentally challenged subject who cannot give independent informed consent or assent.
- In the opinion of the investigator, the subject may have compliance problems with the protocol and the procedures of the protocol.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Optimed Research LTD
Columbus, Ohio, 43235
Oklahoma Institute of Allergy and Asthma Clinical Research
Oklahoma City, Oklahoma, 73131
Allergy & Clinical Immunology Associates
Pittsburgh, Pennsylvania, 15241
The South Bend Clinic LLP
South Bend, Indiana, 46617
About this study
Official title: A Multicenter, Randomized, Cross-over, Open-label Study to Evaluate IGSC 20% Flexible Dosing Including Daily Push Dosing In Treatment-Experienced Subjects With Primary Immunodeficiency (PI) and Evaluation of Loading/Maintenance IGSC 20% in Treatment-Naïve Subjects With PI
This is a prospective, multi-center, randomized, open-label, 2-period cross-over study (16 weeks per treatment period) to evaluate flexible dosing and daily push dosing of IGSC 20% in treatment-experienced subjects with PI. An additional, separate cohort of treatment-naïve, non-randomized subjects who will not be part of the crossover are included and will receive a loading dose of 5 consecutive daily doses of IGSC 20% followed by weekly infusions of IGSC 20% starting Week 1 (Day 8) through Week 32 (end of Treatment Phase).
For treatment-experienced subjects, the study consists of a Screening Visit, Baseline Visit, 16-week Treatment Period 1, 16-week Treatment Period 2, and Final Visit/Early Termination Visit. For treatment-naïve subjects, the study consists of a Screening Visit, a Baseline Visit, a 32-week Treatment Phase, and Final Visit/Early Termination Visit.
Approximately 54 treatment-experienced subjects and approximately 6 treatment-naïve subjects will be enrolled at study centers in the United States (US) and European Union (EU).
Read the detailed description
This is a prospective, multi-center, randomized, open-label, 2-period cross-over study (16 weeks per treatment period) to evaluate flexible dosing and daily push dosing of IGSC 20% in treatment-experienced subjects with PI. There is an additional, separate cohort of treatment-naïve, non-randomized subjects with PI who will not be part of the crossover.
Treatment-experienced subjects entering the study will maintain the same IgG dose (mg/kg) received prestudy that will be normalized to the study-assigned dose-time interval (ie, there will be 1:1 correspondence regardless of prestudy route of administration [intravenous [IV] or SC]). Treatment-experienced subjects will be randomized in a 1:1:1 ratio into 1 of 3 parallel cohorts consisting of 18 subjects each as follows:
Cohort 1 (daily push compared with every 2 weeks [biweekly] pump) will evaluate syringe daily push dosing versus every 2 weeks [biweekly] ambulatory pump administration. Subjects will be randomized in a 1:1 ratio to 1 of 2 sequences, either beginning with syringe daily push dosing for 16 weeks and then crossing over to ambulatory pump administration every 2 weeks for 16 weeks or the reverse sequence.
Cohort 2 (daily push compared with once weekly pump) will evaluate syringe daily push dosing versus once weekly ambulatory pump administration. Subjects will be randomized in a 1:1 ratio to 1 of 2 sequences, either beginning with syringe daily push dosing for 16 weeks and then crossing over to ambulatory pump administration once every week for 16 weeks or the reverse sequence.
Cohort 3 (daily push compared with 2 times/week pump) will evaluate syringe daily push dosing versus 2 times/week ambulatory pump administration. Ambulatory pump dosing will take place on preselected days (eg, Monday and Thursday) not less than 3 days apart. The dosing days should remain constant for the duration of the study. Subjects will be randomized in a 1:1 ratio to 1 of 2 sequences, either beginning with syringe daily push dosing for 16 weeks and then crossing over to ambulatory pump administration 2 times/week for 16 weeks or the reverse sequence.
The treatment-naïve cohort will receive a loading dose of 5 consecutive daily doses of IGSC 20% 150 mg/kg/day (Week 0, Days 1-5) followed by weekly infusions of 150 mg/kg starting Week 1 (Day 8) through Week 32 (end of Treatment Phase).
- Conditions
- Primary Immunodeficiency
- Being tested
- IGSC 20% daily push versus every 2 weeks pump, IGSC 20% daily push versus once a week pump, IGSC 20% daily push versus 2 times per week pump, IGSC 20% 150 mg/kg
- 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.
IGSC 20% daily push versus every 2 weeks pumpBiological
IGSC 20% syringe daily push dosing for 16 weeks followed by every 2 weeks pump dosing for 16 weeks or the reverse sequence
IGSC 20% daily push versus once a week pumpBiological
IGSC 20% syringe daily push dosing for 16 weeks followed by once weekly ambulatory pump administration dosing for 16 weeks or the reverse sequence
IGSC 20% daily push versus 2 times per week pumpBiological
IGSC 20% syringe daily push dosing for 16 weeks followed by 2 times/week ambulatory pump administration on preselected days (eg, Monday and Thursday) not less than 3 days apart for 16 weeks or the reverse sequence
IGSC 20% 150 mg/kgBiological
loading dose of IGSC 20% consisting of 5 consecutive daily doses of 150 mg/kg/day (Week 0, Days 1-5) followed by weekly infusions of IGSC 20% 150 mg/kg starting Week 1 (Day 8) through Week 32 using an infusion SC pump
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | IGSC 20% daily push versus every 2 weeks pump or the reverse sequence Receives: Biological: IGSC 20% daily push versus every 2 weeks pump |
| Cohort 2 | Experimental | IGSC 20% daily push versus once a week pump or the reverse sequence Receives: Biological: IGSC 20% daily push versus once a week pump |
| Cohort 3 | Experimental | IGSC 20% daily push versus 2 times per week pump or the reverse sequence Receives: Biological: IGSC 20% daily push versus 2 times per week pump |
| Treatment-Naive IGSC 20% pump dosing | Experimental | IGSC 20% 150 mg/kg Receives: Biological: IGSC 20% 150 mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Steady-state mean trough (predose) concentration of total IgG
Steady-state mean trough (predose) concentration following SC administration of IGSC 20% in treatment-experienced subjects
Measured: Baseline to Week 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2019
- Study startDec 2019 (estimated)
- Primary completionSep 2020 (estimated)
- Study completionSep 2020 (estimated)
Why it stopped: Due to the regulatory approval of the product in this indication, a large portion of the study becomes unnecessary.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grifols Therapeutics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03814798
- Sponsor's protocol ID
- GC1701
- Status last verified
- Apr 2020
- First submitted
- 22 Jan 2019
- Last updated
- 10 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Cross-over, Open-label Study to Evaluate IGSC 20% Flexible Dosing Including Daily Push Dosing In Treatment-Experienced Subjects With Primary Immunodeficiency (PI) and Evaluation of Loading/Maintenance IGSC 20% in Treatment-Naïve Subjects With PI
- ClinicalTrials.gov ID
- NCT03814798
- Acronym / sponsor ID
- GC1701
- Conditions
- Primary Immunodeficiency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to the regulatory approval of the product in this indication, a large portion of the study becomes unnecessary.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Grifols Therapeutics LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2019 (estimated)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 24 Jan 2019 (actual)
- 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.
This is a prospective, multi-center, randomized, open-label, 2-period cross-over study (16 weeks per treatment period) to evaluate flexible dosing and daily push dosing of IGSC 20% in treatment-experienced subjects with PI. An additional, separate cohort of treatment-naïve, non-randomized subjects who will not be part of the crossover are included and will receive a loading dose of 5 consecutive daily doses of IGSC 20% followed by weekly infusions of IGSC 20% starting Week 1 (Day 8) through Week 32 (end of Treatment Phase).
For treatment-experienced subjects, the study consists of a Screening Visit, Baseline Visit, 16-week Treatment Period 1, 16-week Treatment Period 2, and Final Visit/Early Termination Visit. For treatment-naïve subjects, the study consists of a Screening Visit, a Baseline Visit, a 32-week Treatment Phase, and Final Visit/Early Termination Visit.
Approximately 54 treatment-experienced subjects and approximately 6 treatment-naïve subjects will be enrolled at study centers in the United States (US) and European Union (EU).
Detailed description
This is a prospective, multi-center, randomized, open-label, 2-period cross-over study (16 weeks per treatment period) to evaluate flexible dosing and daily push dosing of IGSC 20% in treatment-experienced subjects with PI. There is an additional, separate cohort of treatment-naïve, non-randomized subjects with PI who will not be part of the crossover.
Treatment-experienced subjects entering the study will maintain the same IgG dose (mg/kg) received prestudy that will be normalized to the study-assigned dose-time interval (ie, there will be 1:1 correspondence regardless of prestudy route of administration [intravenous [IV] or SC]). Treatment-experienced subjects will be randomized in a 1:1:1 ratio into 1 of 3 parallel cohorts consisting of 18 subjects each as follows:
Cohort 1 (daily push compared with every 2 weeks [biweekly] pump) will evaluate syringe daily push dosing versus every 2 weeks [biweekly] ambulatory pump administration. Subjects will be randomized in a 1:1 ratio to 1 of 2 sequences, either beginning with syringe daily push dosing for 16 weeks and then crossing over to ambulatory pump administration every 2 weeks for 16 weeks or the reverse sequence.
Cohort 2 (daily push compared with once weekly pump) will evaluate syringe daily push dosing versus once weekly ambulatory pump administration. Subjects will be randomized in a 1:1 ratio to 1 of 2 sequences, either beginning with syringe daily push dosing for 16 weeks and then crossing over to ambulatory pump administration once every week for 16 weeks or the reverse sequence.
Cohort 3 (daily push compared with 2 times/week pump) will evaluate syringe daily push dosing versus 2 times/week ambulatory pump administration. Ambulatory pump dosing will take place on preselected days (eg, Monday and Thursday) not less than 3 days apart. The dosing days should remain constant for the duration of the study. Subjects will be randomized in a 1:1 ratio to 1 of 2 sequences, either beginning with syringe daily push dosing for 16 weeks and then crossing over to ambulatory pump administration 2 times/week for 16 weeks or the reverse sequence.
The treatment-naïve cohort will receive a loading dose of 5 consecutive daily doses of IGSC 20% 150 mg/kg/day (Week 0, Days 1-5) followed by weekly infusions of 150 mg/kg starting Week 1 (Day 8) through Week 32 (end of Treatment Phase).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: IGSC 20% daily push versus every 2 weeks pumpIGSC 20% daily push versus every 2 weeks pump or the reverse sequence |
| Cohort 2 | Experimental | Biological: IGSC 20% daily push versus once a week pumpIGSC 20% daily push versus once a week pump or the reverse sequence |
| Cohort 3 | Experimental | Biological: IGSC 20% daily push versus 2 times per week pumpIGSC 20% daily push versus 2 times per week pump or the reverse sequence |
| Treatment-Naive IGSC 20% pump dosing | Experimental | Biological: IGSC 20% 150 mg/kgIGSC 20% 150 mg/kg |
Who may qualify
- Ages
- 2 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Has documented and confirmed pre-existing diagnosis of PI with features of hypogammaglobulinemia requiring IgG replacement therapy including but not limited to the following humoral-based immunodeficiency syndromes (eg, X-linked agammaglobulinemia, common variable immunodeficiency), and combined immunodeficiency syndromes without lymphocytopenia (eg, hyper immunoglobulin M immunodeficiency syndrome).
- Has not had a SBI or been hospitalized for infection of any etiology (eg, viral, fungal, parasitic) within the last 3 months prior to screening or during screening.
- Is currently receiving IgG replacement therapy for ≥3 months via IV or SC infusion. Subjects receiving IVIG prior to study must receive a dosage of at least 200 mg/kg per infusion
- Has Screening IgG trough levels ≥500 mg/dL. Note: If screening trough levels are not above this threshold, the subjects will be considered a screen failure, but may be rescreened following dose adjustment of their original IgG replacement therapy regimen and maintaining stable dosing for a period of at least 3 months prior to screening a second time.
- Has signed an informed consent. Note: The subject must sign the informed consent form (ICF) if at least 18 years old; for children of younger age, the subject's parent or legal guardian must sign the ICF and if appropriate/applicable, the subject must sign a Child Assent form approved by the IRB/EC per the institution's requirements
Key exclusion criteria (24 listed)
- Has clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may interfere with successful completion of the trial or place the subject at undue medical risk.
- Has had a known serious adverse reaction to immunoglobulin or any anaphylactic reaction to blood or any blood-derived product
- Has a history of blistering skin disease, clinically significant thrombocytopenia, bleeding disorder, diffuse rash, recurrent skin infections, or other disorders where SC therapy would be contraindicated during the study.
- Has known isolated IgG subclass deficiency; isolated specific antibody deficiency (SAD) or selective IgG deficiency; or transient hypogammaglobulinemia of infancy. Note: Subjects are not to be enrolled if their primary PI diagnosis does not entail an actual quantitative deficit in total IgG. For example, SAD is defined as an impaired specific IgG response to pneumococcal vaccine with normal serum concentrations of IgG, IgM, and IgA. Isolated IgG subclass deficiency is defined as an abnormally low level of 1 or more IgG subclass in subjects with normal levels of total IgG and IgM.
- Has known selective IgA deficiency (with or without antibodies to IgA) (Note: exclusion is for the specific diagnostic entity. It does not exclude other forms of humoral primary immunodeficiency which have decreased IgA in addition to decreased IgG requiring IgG replacement).
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 |
|---|---|---|
| IGSC 20% daily push versus every 2 weeks pumpIGSC 20% syringe daily push dosing for 16 weeks followed by every 2 weeks pump dosing for 16 weeks or the reverse sequence | Biological | Cohort 1 |
| IGSC 20% daily push versus once a week pumpIGSC 20% syringe daily push dosing for 16 weeks followed by once weekly ambulatory pump administration dosing for 16 weeks or the reverse sequence | Biological | Cohort 2 |
| IGSC 20% daily push versus 2 times per week pumpIGSC 20% syringe daily push dosing for 16 weeks followed by 2 times/week ambulatory pump administration on preselected days (eg, Monday and Thursday) not less than 3 days apart for 16 weeks or the reverse sequence | Biological | Cohort 3 |
| IGSC 20% 150 mg/kgloading dose of IGSC 20% consisting of 5 consecutive daily doses of 150 mg/kg/day (Week 0, Days 1-5) followed by weekly infusions of IGSC 20% 150 mg/kg starting Week 1 (Day 8) through Week 32 using an infusion SC pump | Biological | Treatment-Naive IGSC 20% pump dosing |
Primary outcome
Steady-state mean trough (predose) concentration of total IgG
Time frame: Baseline to Week 32
Steady-state mean trough (predose) concentration following SC administration of IGSC 20% in treatment-experienced subjects
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IGSC 20% daily push versus every 2 weeks pump, IGSC 20% daily push versus once a week pump and IGSC 20% daily push versus 2 times per week pump in people with Primary Immunodeficiency, run by Grifols Therapeutics LLC at 4 sites 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 12 inclusion and 24 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: withdrawn, as of the sponsor's last update on 10 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Steady-state mean trough (predose) concentration of total IgG (time frame: Baseline to Week 32). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Apr 2020.