Efficacy and Safety of Intravenous Immunoglobulin IVIG-F10 in Patients With Primary Immunodeficiencies (PID)
Information source: CSL Behring
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Agammaglobulinemia; IgG Deficiency; Common Variable Immunodeficiency
Intervention: Immunoglobulins Intravenous (Human) (Drug)
Phase: Phase 3
Sponsored by: CSL Behring
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.
Official title: An Open Study to Evaluate the Safety and Efficacy of IVIG-F10 in Patients With Primary Immunodeficiency Diseases (PID)
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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.
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
Minimum age: 3 Years.
Maximum age: 70 Years.
Key Inclusion Criteria:
- Patients with primary immunodeficiency
- Regular IVIG therapy for at least 6 months prior to receiving IVIG-F10
Key Exclusion Criteria:
- Allergic reactions to immunoglobulins or other blood products
- Steroids (oral and parenteral, daily ≥0. 15 mg of prednisone equivalent/kg/day
- History of cardiac insufficiency
Locations and Contacts
Starting date: September 2004
Ending date: January 2006
Last updated: March 7, 2006