Status:
COMPLETED
Safety and Efficacy of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)
Lead Sponsor:
CSL Behring
Conditions:
Agammaglobulinemia
IgG Deficiency
Eligibility:
All Genders
4-71 years
Phase:
PHASE3
Brief Summary
The objectives of this trial are the assessment of safety and efficacy of IgPro10 in patients with PID, and the assessment of tolerability of high infusion rates. To demonstrate safety, the number of ...
Eligibility Criteria
Inclusion
- Key
- Patients with CVID (Common Variable Immunodeficiency) or XLA (X-linked agammaglobulinemia) who:
- Participated in the Phase III clinical study with intravenous IgPro10 (study number ZLB03\_002CR) at 3- or 4- weekly intervals for 12 months (referred to as 'old' subjects)
- OR
- Were ≥ 6 years of age, were on other stable intravenous immunoglobulin therapy (200-800 mg IgG per kg body weight) at 3- or 4-week intervals for at least 6 months, AND were interested in participating in the Phase III clinical study with subcutaneous IgPro20 (study number ZLB04\_009CR) (referred to as 'new' subjects)
- Written informed consent
- Key
Exclusion
- Diagnosis of epilepsia
- Insulin dependent diabetes
- Administration of steroids (daily ≥ 0.15 mg prednisone equivalent/kg/day) or other immunosuppressive drugs
- History of cardiac insufficiency (NYHA III/IV), cardiomyopathy, congestive heart failure, severe hypertension
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00322556
Start Date
November 1 2005
End Date
April 1 2008
Last Update
October 26 2012
Active Locations (10)
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1
Contact CSL Behring for facility details
Los Angeles, California, United States, 90027
2
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Centennial, Colorado, United States, 80112
3
Contact CSL Behring for facility details
North Palm Beach, Florida, United States, 33408
4
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St. Petersburg, Florida, United States, 33701