Efficacy and Safety of Intravenous Immunoglobulin IVIG-F10 in Patients With Primary Immunodeficiencies (PID)

An Open Study to Evaluate the Safety and Efficacy of IVIG-F10 in Patients With Primary Immunodeficiency Diseases (PID)

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 overall infections, the tolerability and safety of IVIG-F10 are studied.

Key Inclusion Criteria:

• Patients with primary immunodeficiency
• Regular IVIG therapy for at least 6 months prior to receiving IVIG-F10

Key Exclusion Criteria:

• 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