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NCT03351933 · ClinicalTrials.gov registry record · Phase 4
Anti-Hepatitis A Virus, Pharmacokinetics, and Safety of Immune Globulin (Human)
A Phase 4 study, sponsored by Grifols Therapeutics.
- Completed
- Registry status
- Phase 4
- Development phase
- 28
- Enrollment target
NCT03351933: Completed Phase 4 study, sponsored by Grifols Therapeutics.
NCT03351933 is a Phase 4 study that has completed, run by Grifols Therapeutics. The registered enrollment target is 28 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03351933, a Phase 4 study, has completed, sponsored by Grifols Therapeutics.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 28 participants
- Enrollment target
Study 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. 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.
Primary Outcome
Percentage of subjects maintaining anti-HAV antibody levels ≥10 mIU/mL up to Day 60 following study treatment administration.
Interventions
- BIOLOGICAL Immune Globulin (Human)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2017-10-31 |
| Est. Completion | 2018-07-19 |
| Phase | Phase 4 |
What the finished NCT03351933 record still lists
NCT03351933 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Immune Globulin (Human) is the first listed.
NCT03351933 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03351933 about?
NCT03351933 is a clinical study titled "Anti-Hepatitis A Virus, Pharmacokinetics, and Safety of Immune Globulin (Human)". 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 int...
What is the current status of trial NCT03351933?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 28 participants. The study started on 2017-10-31. Estimated completion is 2018-07-19.
What interventions are being tested in trial NCT03351933?
The interventions under investigation include: Immune Globulin (Human) (BIOLOGICAL).
Who is sponsoring clinical trial NCT03351933?
This trial is sponsored by Grifols Therapeutics, which has 34 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03351933's enrollment target sits among peer trials
28 1635th of 2000 higher than 350 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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