Efficacy and Safety 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 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
Sites / Locations
Arms of the Study
Arm 1
Experimental
IgPro10