Efficacy and Safety of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)
Phase 3
Completed
- Conditions
- AgammaglobulinemiaIgG DeficiencyCommon Variable Immunodeficiency
- Interventions
- Drug: Immunoglobulins Intravenous (Human)
- Registration Number
- NCT00168025
- Lead Sponsor
- CSL Behring
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 89
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 immunosuppressive drugs
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description IgPro10 Immunoglobulins Intravenous (Human) -
- Primary Outcome Measures
Name Time Method Annualized rate of acute serious bacterial infections
- Secondary Outcome Measures
Name Time Method 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