Efficacy and Safety of Intravenous Immunoglobulin IVIG-F10 in Patients With Primary Immunodeficiencies (PID)
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.
|Agammaglobulinemia IgG Deficiency Common Variable Immunodeficiency||Drug: Immunoglobulins Intravenous (Human)||Phase 3|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||An Open Study to Evaluate the Safety and Efficacy of IVIG-F10 in Patients With Primary Immunodeficiency Diseases (PID)|
- 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
|Study Start Date:||September 2004|
|Study Completion Date:||September 2005|