NCT00168025

Efficacy and Safety of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)

A Multicenter Study on the Efficacy, Safety and Pharmacokinetics of IgPro10 in Patients With Primary Immunodeficiency (PID)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: CSL Behring · Industry
• Sex: All
• Age: 3 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to demonstrate the effect of IgPro10 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 IgPro10 are studied. A part of the patients are participating in a pharmacokinetic substudy.

Conditions

• Agammaglobulinemia
• IgG Deficiency
• Common Variable Immunodeficiency

Interventions

Type	Name	Description
DRUG	Immunoglobulins Intravenous (Human)

Timeline

• Start date: 2004-09-01
• Completion: 2006-03-01
• First posted: 2005-09-14
• Last updated: 2012-06-06