Study to Evaluate Safety and Pharmacokinetics of BIVIGAM® in Primary Immune Deficiency Subjects Aged 2 to 16

Phase 4 Completed 16 enrolled ADMA Biologics, Inc.

NaSingle-groupOpen-labelOther

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.

Timeline

Start: 2016-12-29
Primary completion: 2022-08-30
Completion: 2022-12-31

Publications

Dumas T, Mehr S, Avila R, Doman A, Kestenberg K, Melamed I. Pharmacokinetic Model Based Sensitivity Analysis to Lower Recruitment Burden for Young Children Requiring Intravenous Immunoglobulin G Replacement. CPT Pharmacometrics Syst Pharmacol. 2026 Jun;15(6):e70275. doi: 10.1002/psp4.70275.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Immune Globulin Intravenous (Human)	Protein / enzyme biologic	—	Intravenous

Indications

No indication recorded.