NCT00322556

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: CSL Behring · Industry
• Sex: All
• Age: 4 Years – 71 Years
• Healthy volunteers: Not accepted

Summary

The objectives of this trial are the assessment of safety and efficacy of IgPro10 in patients with PID, and the assessment of tolerability of high infusion rates. To demonstrate safety, the number of infusions temporally associated with AEs, the rate, severity and relationship of all AEs and the vital sign changes during each infusion will be evaluated.

Conditions

• Agammaglobulinemia
• IgG Deficiency
• Common Variable Immunodeficiency

Interventions

Type	Name	Description
DRUG	Immunoglobulins Intravenous (Human)	Liquid formulation; treatment schedule every 3 or 4 weeks using an individualized regimen with a dose of 0.2 - 0.8 g IgG per kg bw

Timeline

• Start date: 2005-11-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2006-05-08
• Last updated: 2012-10-26
• Results posted: 2012-10-26

Locations

10 sites across 1 country: United States