Study to Evaluate Safety and Pharmacokinetics of BIVIGAM® in Primary Immune Deficiency Subjects Aged 2 to 16
Public ClinicalTrials.gov record NCT03164967. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03164967
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 16 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 2 Years to 16 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 28, 2016
- Primary completion
- Aug 29, 2022
- Completion
- Dec 30, 2022
- Last update posted
- Jan 31, 2023
2016 – 2022
United States locations
- U.S. sites
- 8
- U.S. states
- 6
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| IMMUNOe Research Centers | Centennial | Colorado | 80112 | — |
| Duke University Medical Center | Durham | Florida | 27710 | — |
| Allergy Associates of the Palm Beaches | North Palm Beach | Florida | 33408 | — |
| USF Health, Pediatric Allergy, Immunology & Rheumatology | St. Petersburg | Florida | 33701 | — |
| Ohio Clinical Research Associates | Mayfield Heights | Ohio | 44124 | — |
| Oklahoma Institute of Allergy and Asthma Clinical Research | Oklahoma City | Oklahoma | 73131 | — |
| Discovery Clinical Trials | Dallas | Texas | 75225 | — |
| Lysosomal Rare Disorders Research & Treatment Center | Fairfax | Virginia | 22030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03164967, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 31, 2023 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03164967 live on ClinicalTrials.gov.