RabiesPhase 1NCT02139657
An Open-label, Single-Arm Study to Evaluate the Safety and Rabies Virus Antibody Titers of Intramuscularly Administered Rabies Immune Globulin (Human)
A Phase 1 study testing RIG-C in people with Rabies, run by Grifols Therapeutics LLC at 1 site in United States.
Trial summary
This is a single-arm, open-label study of Rabies Immune Globulin (Human), Caprylate/Chromatography Purified (RIG-C), in approximately 12 healthy subjects. The purpose of this study is to characterize the rabies virus-specific antibody titer after a single intramuscular injection of 20 IU/kg RIG-C and to evaluate the… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Rabies
- What is being tested?
- RIG-C
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to May 2014
- Phase
- Phase 1
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- In good health in the judgment of the Investigator as determined by medical history, physical examination, and screening laboratory assessments.
- Female of childbearing potential must have a negative result on the screening serum pregnancy test and must agree to practice contraception by a method of proven reliability (includes abstinence) for the duration of the study.
Who cannot join
- Pregnant or lactating females.
- Clinical evidence of any significant acute or chronic disease that may interfere with successful completion of the trial.
- Clinically significant history of the following: cardiovascular disease, hyperlipidemia, serious respiratory disease including bronchitis or asthma, endocrine disorder, liver disease, glaucoma, gastrointestinal disease, disorder of the reticuloendothelial system, or neurologic illness.
- History of angioedema or nephrotic syndrome.
- Non-controlled arterial hypertension.
- Anemia at screening.
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- Significant proteinuria (> 1 + on urine dipstick) and/or has a history of acute renal failure and/or severe renal impairment or a blood urea nitrogen or creatinine more than 2.5 times the upper limit of normal at screening and/or currently receiving dialysis.
- Elevated liver enzymes (aspartate transaminase, alanine aminotransferase) and Gamma-glutamyl Transferase) equal to or greater than 1.5 times the upper limit at screening.
- Previously received the rabies vaccine and/or rabies immune globulin.
- Received infusion of a blood/plasma product or fraction within the past 12 months, including any type of immune globulin.
- Known adverse reaction to administration of any immune globulin or other blood/plasma products.
- Experienced anaphylactic shock with the administration of blood/plasma products.
- Known medical history of selective immunoglobulin A (IgA) deficiency.
- Received any corticosteroids, immunosuppressants, or immunomodulators within 6 weeks prior to screening.
- Expects to receive oral or topical non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen, antihypertensives, and/or antihistamines 24 hours before or after investigational product administration during the Baseline/Treatment, Study Day 0 visit.
- Currently receiving any anti-viral treatment.
- Screening laboratory results indicative of an acute or chronic infection with hepatitis A virus (HAV), hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), or parvovirus B19 (B19V).
- Participated in another clinical trial within 30 days prior to screening (imaging studies without investigative treatments are permitted) or has received any investigational products within the previous 3 months.
- Not willing to postpone receiving any live virus vaccines until 3 months after receiving investigational product.
- History of a psychiatric illness requiring hospitalization.
- Known substance or prescription drug abuse in the past 12 months.
- Any active medical illness that the Investigator may consider a potential confounding condition that would interfere with the study visits and/or procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Single-arm Study to Evaluate the Safety and Antibody Titers Specific to the Rabies Virus in Healthy Subjects After Receiving a Single Dose of Intramuscularly Administered Rabies Immune Globulin (Human)
This is a single-arm, open-label study of Rabies Immune Globulin (Human), Caprylate/Chromatography Purified (RIG-C), in approximately 12 healthy subjects. The purpose of this study is to characterize the rabies virus-specific antibody titer after a single intramuscular injection of 20 IU/kg RIG-C and to evaluate the safety and tolerability of RIG-C.
- Conditions
- Rabies
- Being tested
- RIG-C
- Keywords
- Rabies, Rabies virus, Rhabdoviridae, Rabies immune globulin, Rabies antibodies, Passive rabies immunization
- Medical subject headings
- Rabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RIG-CBiological
Also called Rabies Immune Globulin (Human), Caprylate/Chromatography Purified
| Study group | Role | What they receive |
|---|---|---|
| RIG-C | Experimental | Single 20 IU/kg dose of RIG-C by intramuscular injection Receives: Biological: RIG-C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rabies Virus Antibody Titer
Measured: 10 days post-RIG-C dosing
Secondary outcomes (1)
Number of subjects who discontinue due to adverse events
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2014 (estimated)
- Study startMar 2014
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RabiesStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 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
- NCT02139657
- Sponsor's protocol ID
- GTI1301
- Status last verified
- Jul 2014
- First submitted
- 28 Apr 2014
- Last updated
- 24 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Hanna K, Cruz MC, Mondou E, Corsi E, Vandeberg P. Safety and neutralizing rabies antibody in healthy subjects given a single dose of rabies immune globulin caprylate/chromatography purified. Clin Pharmacol. 2018 Jun 26;10:79-88. doi: 10.2147/CPAA.S166454. eCollection 2018.
PubMed 29983597
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-arm Study to Evaluate the Safety and Antibody Titers Specific to the Rabies Virus in Healthy Subjects After Receiving a Single Dose of Intramuscularly Administered Rabies Immune Globulin (Human)
- ClinicalTrials.gov ID
- NCT02139657
- Acronym / sponsor ID
- GTI1301
- Conditions
- Rabies
- Keywords
- Rabies, Rabies virus, Rhabdoviridae, Rabies immune globulin, Rabies antibodies, Passive rabies immunization
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Grifols Therapeutics LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 15 May 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.
This is a single-arm, open-label study of Rabies Immune Globulin (Human), Caprylate/Chromatography Purified (RIG-C), in approximately 12 healthy subjects. The purpose of this study is to characterize the rabies virus-specific antibody titer after a single intramuscular injection of 20 IU/kg RIG-C and to evaluate the safety and tolerability of RIG-C.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RIG-C | Experimental | Biological: RIG-CSingle 20 IU/kg dose of RIG-C by intramuscular injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- In good health in the judgment of the Investigator as determined by medical history, physical examination, and screening laboratory assessments.
- Female of childbearing potential must have a negative result on the screening serum pregnancy test and must agree to practice contraception by a method of proven reliability (includes abstinence) for the duration of the study.
Key exclusion criteria (22 listed)
- Pregnant or lactating females.
- Clinical evidence of any significant acute or chronic disease that may interfere with successful completion of the trial.
- Clinically significant history of the following: cardiovascular disease, hyperlipidemia, serious respiratory disease including bronchitis or asthma, endocrine disorder, liver disease, glaucoma, gastrointestinal disease, disorder of the reticuloendothelial system, or neurologic illness.
- History of angioedema or nephrotic syndrome.
- Non-controlled arterial hypertension.
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 |
|---|---|---|
| RIG-CAlso: Rabies Immune Globulin (Human), Caprylate/Chromatography Purified | Biological | RIG-C |
Primary outcome
Rabies Virus Antibody Titer
Time frame: 10 days post-RIG-C dosing
1 secondary outcome
Number of subjects who discontinue due to adverse events
Time frame: 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2014.
- Derived from this study: PubMed 29983597Hanna K, Cruz MC, Mondou E, Corsi E, Vandeberg P. Safety and neutralizing rabies antibody in healthy subjects given a single dose of rabies immune globulin caprylate/chromatography purified. Clin Pharmacol. 2018 Jun 26;10:79-88. doi: 10.2147/CPAA.S166454. eCollection 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RIG-C in people with Rabies, run by Grifols Therapeutics LLC 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 2 inclusion and 22 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: finished, as of the sponsor's last update on 24 Jul 2014. 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 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.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rabies Virus Antibody Titer (time frame: 10 days post-RIG-C dosing). 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 NCT02139657, which also lists 1 linked publication.
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 Jul 2014.