Clinical Trial: Efficacy and Safety of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Multicenter Study on the Efficacy, Safety and Pharmacokinetics of IgPro10 in Patients With Primary Immunodeficiency (PID)
Brief 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.
Detailed Summary:
Sponsor: CSL Behring
Current Primary Outcome: Annualized rate of acute serious bacterial infections
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Number of infections
- Number of days out of work / school due to underlying PID
- Adverse events temporally associated with study drug infusion
- Trough levels of total IgG serum concentrations
Original Secondary Outcome: Same as current
Information By: CSL Behring
Dates:
Date Received: September 12, 2005
Date Started: September 2004
Date Completion:
Last Updated: June 5, 2012
Last Verified: June 2012
