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NCT03164967 · ClinicalTrials.gov registry record · Phase 4
Study to Evaluate Safety and Pharmacokinetics of BIVIGAM® in Primary Immune Deficiency Subjects Aged 2 to 16
A Phase 4 study, sponsored by ADMA Biologics.
- Completed
- Registry status
- Phase 4
- Development phase
- 16
- Enrollment target
NCT03164967 is a Phase 4 study that has completed, run by ADMA Biologics. The registered enrollment target is 16 participants.
The verdict
NCT03164967, a Phase 4 study, has completed, sponsored by ADMA Biologics.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 16 participants
- Enrollment target
Study Summary
This study is part of the BIVIGAM® post marketing requirement (PMR). It is being conducted in subjects aged 2-16 with primary immune deficiency disorders associated with defects in humoral immunity to generate additional data on these populations, and more specifically safety and pharmacokinetic (PK) assessments.
Interventions
- BIOLOGICAL Bivigam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2016-12-29 |
| Est. Completion | 2022-12-31 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03164967
The ClinicalTrials.gov registry entry for NCT03164967 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ADMA Biologics, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Bivigam is the first listed.
NCT03164967 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03164967 about?
NCT03164967 is a clinical study titled "Study to Evaluate Safety and Pharmacokinetics of BIVIGAM® in Primary Immune Deficiency Subjects Aged 2 to 16". This study is part of the BIVIGAM® post marketing requirement (PMR). It is being conducted in subjects aged 2-16 with primary immune deficiency disorders associated with defects in humoral immunity to generate additional data on these populations, and more specifically safety and pharmacokinetic (PK...
What is the current status of trial NCT03164967?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 16 participants. The study started on 2016-12-29. Estimated completion is 2022-12-31.
What interventions are being tested in trial NCT03164967?
The interventions under investigation include: Bivigam (BIOLOGICAL).
Who is sponsoring clinical trial NCT03164967?
This trial is sponsored by ADMA Biologics, which has 5 total clinical trials registered on ClinicalTrials.gov.
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