Status:
COMPLETED
Efficacy and Safety of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)
Lead Sponsor:
CSL Behring
Conditions:
Agammaglobulinemia
IgG Deficiency
Eligibility:
All Genders
3-70 years
Phase:
PHASE3
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 overa...
Eligibility Criteria
Inclusion
- Key
- Patients with primary immunodeficiency
- Patients who have received stable IVIG therapy at 3- or 4-weekly intervals for at least 6 months
- Key
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2006
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT00168025
Start Date
September 1 2004
End Date
March 1 2006
Last Update
June 6 2012
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