Efficacy and Safety of Intravenous Immunoglobulin IVIG-F10 in Patients With Primary Immunodeficiencies (PID)

Phase 3 Completed 42 enrolled CSL Behring

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to demonstrate the effect of IVIG-F10 on the prevention of serious bacterial infections in patients with primary immunodeficiency. As secondary endpoints the rate of overall infections, the tolerability and safety of IVIG-F10 are studied.

Timeline

Start: 2004-09
Primary completion: —
Completion: 2005-09

Outcome

Met primary endpoint

paper upper 95% confidence interval was 39.4%, meeting the Food and Drug Administration (FDA) criterion for acceptable tolerability PMID 17479360 ↗

Publications

Results Berger M, Cunningham-Rundles C, Bonilla FA, Melamed I, Bichler J, Zenker O, Ballow M. Carimune NF Liquid is a safe and effective immunoglobulin replacement therapy in patients with primary immunodeficiency diseases. J Clin Immunol. 2007 Sep;27(5):503-9. doi: 10.1007/s10875-007-9096-9. Epub 2007 May 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Carimune NF Liquid	Protein / enzyme biologic	278.5 mg/kg	Intravenous
Subject	Carimune NF Liquid	Protein / enzyme biologic	800.7 mg/kg	Intravenous