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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 is a Phase 4 study that has completed, run by Grifols Therapeutics. The registered enrollment target is 28 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03351933
The ClinicalTrials.gov registry entry for NCT03351933 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Grifols Therapeutics, which has 34 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Immune Globulin (Human) is the first listed.
NCT03351933 reports 0 study locations.
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.
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