Status:
COMPLETED
Efficacy and Safety of Intravenous Immunoglobulin IVIG-F10 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 IVIG-F10 on the prevention of serious bacterial infections in patients with primary immunodeficiency. As secondary endpoints the rate of over...
Eligibility Criteria
Inclusion
- Key
- Patients with primary immunodeficiency
- Regular IVIG therapy for at least 6 months prior to receiving IVIG-F10
- Key
Exclusion
- Allergic reactions to immunoglobulins or other blood products
- Steroids (oral and parenteral, daily ≥0.15 mg of prednisone equivalent/kg/day
- History of cardiac insufficiency
- Epilepsia
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
End Date :
September 1 2005
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00168012
Start Date
September 1 2004
End Date
September 1 2005
Last Update
February 11 2011
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