Clinical Trial: Efficacy and Safety of Intravenous Immunoglobulin IVIG-F10 in Patients With Primary Immunodeficiencies (PID)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: An Open Study to Evaluate the Safety and Efficacy of IVIG-F10 in Patients With Primary Immunodeficiency Diseases (PID)
Brief 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.
Detailed Summary:
Sponsor: CSL Behring
Current Primary Outcome: Proportion of infusions temporally (during the infusion and within 48 hours after the end of infusion) associated with one or more adverse events, regardless of relationship.
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Rate of acute serious bacterial infections
- Number of days out of work/school due to underlying PID
- Number of infections
- Rate, severity and relationship of all adverse events
Original Secondary Outcome: Same as current
Information By: CSL Behring
Dates:
Date Received: September 12, 2005
Date Started: September 2004
Date Completion:
Last Updated: February 10, 2011
Last Verified: February 2011
