Open Label, Phase III Study of NABI-IGIV 10% [Immune Globulin Intravenous(Human), 10%] In Subjects With Primary Immune Deficiency Disorders (PIDD)

Phase 3 Completed 63 enrolled ADMA Biologics, Inc.

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to determine if NABI-IGIV (10%) \[Immune Globulin Intravenous (Human), 10%\] is safe and effective in preventing serious bacterial infections (SBIs) in the treatment of patients with primary immune deficiency disorders (PIDD) when compared to historical control data.

Timeline

Start: 2007-09
Primary completion: 2009-07
Completion: 2009-07

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	Nabi-IGIV	Protein / enzyme biologic	300 mg/kg	Intravenous
Subject	Nabi-IGIV	Protein / enzyme biologic	800 mg/kg	Intravenous

Open Label, Phase III Study of NABI-IGIV 10% [Immune Globulin Intravenous(Human), 10%] In Subjects With Primary Immune Deficiency Disorders (PIDD)

Summary

Timeline

Publications

Drugs

Indications