Efficacy and Safety of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)
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.
|Agammaglobulinemia IgG Deficiency Common Variable Immunodeficiency||Drug: Immunoglobulins Intravenous (Human)||Phase 3|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multicenter Study on the Efficacy, Safety and Pharmacokinetics of IgPro10 in Patients With Primary Immunodeficiency (PID)|
- Annualized rate of acute serious bacterial infections
- 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
|Study Start Date:||September 2004|
|Study Completion Date:||March 2006|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00168025
|Study Director:||Program Director||CSL Behring|