Anti-Hepatitis A Antibody Levels in Heathy SubjectsPhase 4GamaSTANNCT03351933
Anti-Hepatitis A Virus, Pharmacokinetics, and Safety of Immune Globulin (Human)
A Phase 4 study testing Immune Globulin (Human) in people with Anti-Hepatitis A Antibody Levels in Heathy Subjects, run by Grifols Therapeutics LLC at 1 site in United States.
Trial summary
This was a single center, open-label, single-arm study in which approximately 28 Hepatitis A virus (HAV)-seronegative healthy subjects were enrolled. There was a screening period of up to 28 days during which subjects were screened for enrollment in the study. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anti-Hepatitis A Antibody Levels in Heathy Subjects
- What is being tested?
- Immune Globulin (Human)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2017to 19 Jul 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Male subjects from 18 to 55 years of age, inclusive, or female subjects from 18 to 65 years of age, inclusive
- Subjects with a body mass index (BMI) of 18.5 to 29.9 kg/m2
- Body weight greater than or equal to 50 kg at screening
- Subjects willing and able to provide written informed consent
- Subjects in good health in the judgment of the Investigator, as determined by medical history, physical examination, vital signs, ECG and laboratory assessments
- A female study subject must meet one of the following criteria:
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- If a female of childbearing potential - agrees to use one of the accepted contraceptive regimens from at least 30 days prior to study treatment administration and during the entire study duration. An acceptable method of contraception includes one of the following:
- Abstinence from heterosexual intercourse (i.e. when abstinence is the preferred and usual lifestyle of the subject; periodic abstinence is not acceptable)
- Non-estrogen containing hormonal contraceptives (birth control pills, injectable/implant/insertable hormonal birth control products, transdermal patch)
- Intrauterine device without hormones
- Condom with spermicide
- Diaphragm or cervical cap with spermicide
- Vasectomized partner (minimum 6 months since vasectomy prior to study treatment administration)
- If a female of non-childbearing potential - should be surgically sterile (i.e. has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation) or in a menopausal state (at least 1 year without menses prior to study treatment administration)
- A male study subject must agree to use one of the accepted contraceptive regimens during the entire study duration;
- Abstinence from heterosexual intercourse
- Female partner with condom with spermicide used by male study subject
- Female partner of non-childbearing potential
- Male sterilization (if proof of sterilization is not provided, the subject must agree to use one of the above accepted contraceptive methods)
- A male study subject must agree not to impregnate a female or donate sperm during the entire study duration
Who cannot join
- Subject vaccinated against HAV, as documented the in medical history at the screening visit
- Subject with positive anti-HAV antibodies in blood sample at the screening visit
- Subject who previously received any type of IG, including HAV IG within the past 12 months prior to study treatment administration
- Subject with prolonged International Normalized Ratio (INR) or activated partial thromboplastin time (aPTT) at the screening visit
- Subject with a platelet count below 100×109/L at the screening visit
- Subject suffering from some acute or chronic medical, surgical or psychiatric significant condition or laboratory abnormality at the screening visit or prior to study treatment administration that, according to Investigator judgement, may increase the risk associated with study participation or study treatment administration, or may interfere with the successful completion or interpretation of the study results
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- Subject with a history of the following: angioedema, cardiac arrhythmia, angina pectoris, myocardial infarction, cerebrovascular accident, cardiac failure, thrombotic events, embolism, coagulopathy, diabetes mellitus, hyperlipidaemia, nephrotic syndrome, acute renal injury, chronic obstructive pulmonary disease, asthma, hepatic disease, reticuloendothelial system dysfunction, or nervous system disorder
- Subject with known personal or family history of abnormal bleeding episodes
- Subject not willing to receive study treatment via IM route of administration or unable to receive study treatment via IM route of administration
- Subject with cardiovascular risk factors based on medical history: active tobacco smoking and/or ongoing diabetes mellitus at the screening visit
- Subject with thrombosis risk factors: prolonged immobilization within 2 months prior to the screening visit, history of venous or arterial thrombosis, use of estrogens (30 days prior to the study drug administration), indwelling central vascular catheters and hyperviscosity or hypercoagulable states
- Subject with known history of hypersensitivity/allergic reaction to blood/plasma products
- Subject with known selective IgA deficiency (with or without antibodies to IgA)
- Subject who received any plasma-derived product infusion within 12 months prior to study treatment administration
- Subject who received a blood or plasma transfusion within 12 months prior to study treatment administration
- Subject with systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg at the screening visit and prior to treatment administration
- Subject with anemia (hemoglobin <12 g/dL in women and 13 g/dL in men) at the screening visit
- Subjects with proteinuria (>1+ on urine dipstick), blood urea nitrogen (BUN) or creatinine greater than the upper limit of normal at the screening visit
- Subject with liver enzymes (aspartate aminotransferase [AST], alanine aminotransferase [ALT] and gamma-glutamyl transferase [GGT]) levels greater than the upper limit of normal at screening visit
- Subject who received any dose of parenteral, oral, or inhaled corticosteroids, immunosuppressants, or immunomodulators within 6 weeks prior to the screening visit
- Subject who received any live virus vaccine within five months prior to the screening visit
- Subject not willing to postpone receiving any live virus vaccines until 6 months after receiving IP
- Currently receiving any anti-viral treatment, regardless of the route of administration
- Subject with virus safety laboratory results (serology and/or nucleic acid amplification technology [NAT]) indicative of a current infection with hepatitis A virus (HAV), hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or parvovirus B19 (B19V) at the screening visit
- Participated in another clinical trial within 30 days prior to the screening visit or has received any IPs within 3 months prior to the screening visit
- Positive urine drug panel testing at the screening visit or prior to study treatment administration
- Known or suspected abuse of alcohol, opiates, psychotropic agents or other drugs or chemical substances; or has done so in the 12 months prior to the screening visit
- In the opinion of the Investigator, the subject may have compliance problems with the protocol and the procedures of the protocol
- Subject who has already been included in a previous group for this clinical study
Trial locations and contacts
1 site in 1 country.
United States1 site
Vince & Associates Clinical Research, Inc.
Overland Park, Kansas, 66212
About this study
Official title: A Prospective, Open-Label, Single-Arm Clinical Trial to Assess the Anti-Hepatitis A Virus (HAV) Antibody Levels, Pharmacokinetics, and Safety of a Single Intramuscular Dose of a Polyvalent Human Immune Globulin in HAV Seronegative Healthy Subjects
This was a single center, open-label, single-arm study in which approximately 28 Hepatitis A virus (HAV)-seronegative healthy subjects were enrolled. There was a screening period of up to 28 days during which subjects were screened for enrollment in the study.
Healthy subjects received a single intramuscular (IM) dose of GamaSTAN (0.2 mL/kg), followed by a pharmacokinetic (PK) sampling period of 150 days (approximately 5 half-lives). The protective levels of anti-HAV antibodies were assessed up to 60 days after the administration of GamaSTAN. A PK curve was obtained during the PK sampling period.
Read the detailed description
This was a single center, open-label, single-arm study design, in which approximately 28 subjects received the same study treatment (0.2 mL/kg dose via IM injection). There was no reference therapy in this study.
The study was explained to each subject prior to the subject providing written informed consent. All subjects were screened to ensure that all the inclusion criteria and none of the exclusion criteria were met.
A sufficient number of healthy male and female subjects were qualified by screening assessments and procedures for reporting to the clinical site on Day -1. The healthy subjects received a single IM dose of GamaSTAN (0.2 mL/kg) on Day 1. Subjects were discharged from the clinic on Day 2, following the scheduled assessments and procedures, and returned to the clinical site for the remaining ambulatory PK samples and safety monitoring, and again for the final visit (Day 150).
The total duration of study participation for subjects who completed the study were approximately 178 days.
- Being tested
- Immune Globulin (Human)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immune Globulin (Human)Biological
Also called GamaSTAN
A single 0.2 mL/kg IM injection of Immune Globulin (Human) (GamaSTAN) was administered in healthy subjects.
| Study group | Role | What they receive |
|---|---|---|
| Immune Globulin (Human) GamaSTAN | Experimental | The healthy subjects received a single IM dose of GamaSTAN (0.2 mL/kg), followed by a PK sampling period of 150 days. Receives: Biological: Immune Globulin (Human) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects Maintaining Protective Anti- HAV Antibody Levels
Percentage of subjects maintaining anti-HAV antibody levels ≥10 mIU/mL up to Day 60 following study treatment administration.
Measured: Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2017
- Study start31 Oct 2017
- Primary completion27 Apr 2018
- Study completion19 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anti-Hepatitis A Antibody Levels in Heathy SubjectsStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 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
- NCT03351933
- Sponsor's protocol ID
- GC1703
- Acronym
- GamaSTAN
- Status last verified
- Jul 2019
- First submitted
- 20 Nov 2017
- Last updated
- 30 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Kankam M, Griffin R, Price J, Michaud J, Liang W, Llorens MB, Sanz A, Vince B, Vilardell D. Polyvalent Human Immune Globulin: A Prospective, Open-Label Study Assessing Anti-Hepatitis A Virus (HAV) Antibody Levels, Pharmacokinetics, and Safety in HAV-Seronegative Healthy Subjects. Adv Ther. 2020 May;37(5):2373-2389. doi: 10.1007/s12325-020-01327-9. Epub 2020 Apr 16.
PubMed 32301062
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-Label, Single-Arm Clinical Trial to Assess the Anti-Hepatitis A Virus (HAV) Antibody Levels, Pharmacokinetics, and Safety of a Single Intramuscular Dose of a Polyvalent Human Immune Globulin in HAV Seronegative Healthy Subjects
- ClinicalTrials.gov ID
- NCT03351933
- Acronym / sponsor ID
- GamaSTAN / GC1703
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Grifols Therapeutics LLCIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2017 (actual)
- Primary completion
- 27 Apr 2018 (actual)
- Study completion
- 19 Jul 2018 (actual)
- First posted
- 24 Nov 2017 (actual)
- Results
- Posted 30 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a single center, open-label, single-arm study in which approximately 28 Hepatitis A virus (HAV)-seronegative healthy subjects were enrolled. There was a screening period of up to 28 days during which subjects were screened for enrollment in the study.
Healthy subjects received a single intramuscular (IM) dose of GamaSTAN (0.2 mL/kg), followed by a pharmacokinetic (PK) sampling period of 150 days (approximately 5 half-lives). The protective levels of anti-HAV antibodies were assessed up to 60 days after the administration of GamaSTAN. A PK curve was obtained during the PK sampling period.
Detailed description
This was a single center, open-label, single-arm study design, in which approximately 28 subjects received the same study treatment (0.2 mL/kg dose via IM injection). There was no reference therapy in this study.
The study was explained to each subject prior to the subject providing written informed consent. All subjects were screened to ensure that all the inclusion criteria and none of the exclusion criteria were met.
A sufficient number of healthy male and female subjects were qualified by screening assessments and procedures for reporting to the clinical site on Day -1. The healthy subjects received a single IM dose of GamaSTAN (0.2 mL/kg) on Day 1. Subjects were discharged from the clinic on Day 2, following the scheduled assessments and procedures, and returned to the clinical site for the remaining ambulatory PK samples and safety monitoring, and again for the final visit (Day 150).
The total duration of study participation for subjects who completed the study were approximately 178 days.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Immune Globulin (Human) GamaSTAN | Experimental | Biological: Immune Globulin (Human)The healthy subjects received a single IM dose of GamaSTAN (0.2 mL/kg), followed by a PK sampling period of 150 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Male subjects from 18 to 55 years of age, inclusive, or female subjects from 18 to 65 years of age, inclusive
- Subjects with a body mass index (BMI) of 18.5 to 29.9 kg/m2
- Body weight greater than or equal to 50 kg at screening
- Subjects willing and able to provide written informed consent
- Subjects in good health in the judgment of the Investigator, as determined by medical history, physical examination, vital signs, ECG and laboratory assessments
Key exclusion criteria (29 listed)
- Subject vaccinated against HAV, as documented the in medical history at the screening visit
- Subject with positive anti-HAV antibodies in blood sample at the screening visit
- Subject who previously received any type of IG, including HAV IG within the past 12 months prior to study treatment administration
- Subject with prolonged International Normalized Ratio (INR) or activated partial thromboplastin time (aPTT) at the screening visit
- Subject with a platelet count below 100×109/L at the screening visit
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 |
|---|---|---|
| Immune Globulin (Human)Also: GamaSTANA single 0.2 mL/kg IM injection of Immune Globulin (Human) (GamaSTAN) was administered in healthy subjects. | Biological | Immune Globulin (Human) GamaSTAN |
Primary outcome
Percentage of Subjects Maintaining Protective Anti- HAV Antibody Levels
Time frame: Day 60
Percentage of subjects maintaining anti-HAV antibody levels ≥10 mIU/mL up to Day 60 following study treatment administration.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32301062Kankam M, Griffin R, Price J, Michaud J, Liang W, Llorens MB, Sanz A, Vince B, Vilardell D. Polyvalent Human Immune Globulin: A Prospective, Open-Label Study Assessing Anti-Hepatitis A Virus (HAV) Antibody Levels, Pharmacokinetics, and Safety in HAV-Seronegative Healthy Subjects. Adv Ther. 2020 May;37(5):2373-2389. doi: 10.1007/s12325-020-01327-9. Epub 2020 Apr 16.
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 4 study testing Immune Globulin (Human) in people with Anti-Hepatitis A Antibody Levels in Heathy Subjects, 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 20 inclusion and 29 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 30 Jul 2019. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Subjects Maintaining Protective Anti- HAV Antibody Levels (time frame: Day 60). 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 NCT03351933, 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 30 Jul 2019.