Efficacy and Safety of Intravenous Immunoglobulin IgPro10 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 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
A part of the patients are participating in a pharmacokinetic substudy.
Official title: A Multicenter Study on the Efficacy, Safety and Pharmacokinetics of IgPro10 in Patients With Primary Immunodeficiency (PID)
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: 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
Minimum age: 3 Years.
Maximum age: 70 Years.
Key Inclusion Criteria:
- Patients with primary immunodeficiency
- Patients who have received stable IVIG therapy at 3- or 4-weekly intervals for at
least 6 months
Key Exclusion Criteria:
- Newly diagnosed PID
- Allergic reactions to immunoglobulins or other blood products
- Administration of steroids (daily ≥ 0. 15 mg prednisone equivalent/kg/day) or other
- Concomitant diseases such as hypoalbuminemia, protein-losing enteropathies, kidney
diseases with proteinuria, malignancies of lymphoid cells (e. g. lymphocytic leukemia),
and recent history of migraine
- History of cardiac insufficiency (NYHA III/IV), cardiomyopathy, congestive heart
failure, severe hypertension
Locations and Contacts
Starting date: September 2004
Last updated: January 5, 2007