Safety and Efficacy of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)
Agammaglobulinemia, IgG Deficiency, Common Variable Immunodeficiency
About this trial
This is an interventional treatment trial for Agammaglobulinemia focused on measuring Immunoglobulin Intravenous, Agammaglobulinemia, Hypogammaglobulinemia, Common variable immunodeficiency, Immunoglobulin G, Children
Eligibility Criteria
Key Inclusion Criteria: 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 Criteria: 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
Sites / Locations
- Contact CSL Behring for facility details
- Contact CSL Behring for facility details
- Contact CSL Behring for facility details
- Contact CSL Behring for facility details
- Contact CSL Behring for facility details
- Contact CSL Behring for facility details
- Contact CSL Behring for facility details
- Contact CSL Behring for facility details
- Contact CSL Behring for facility details
- Contact CSL Behring for facility details
Arms of the Study
Arm 1
Experimental
IgPro10
See Intervention Description