Trials / Completed
CompletedNCT03164967
Study to Evaluate Safety and Pharmacokinetics of BIVIGAM® in Primary Immune Deficiency Subjects Aged 2 to 16
A Phase IV, Multicenter, Open-label Study to Evaluate the Safety and Pharmacokinetics of BIVIGAM® in Primary Immune Deficiency Disorders in Subjects Aged 2 to 16
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- ADMA Biologics, Inc. · Industry
- Sex
- All
- Age
- 2 Years – 16 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Bivigam |
Timeline
- Start date
- 2016-12-29
- Primary completion
- 2022-08-30
- Completion
- 2022-12-31
- First posted
- 2017-05-24
- Last updated
- 2023-02-01
Locations
8 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03164967. Inclusion in this directory is not an endorsement.