Efficacy, Safety and Kinetics Study of Octagam 10% in Primary Immunodeficiency Diseases

Inclusion Criteria: * Confirmed diagnosis of primary immunodeficiency (acc. WHO) * Previous treatment with commercial Octagam 5% every 3-4 weeks for at least 6 infusions intervals * Documented IgG trough levels of the two previous infusions before enrollment with a value of at least 5.5 g/L for both Exclusion Criteria: * Acute infection requiring intravenous antibiotic treatment within two weeks before screening * Exposure to blood or any blood product or derivative other than commercially available Octagam 5%, within the past 3 months * History of hypersensitivity to blood or plasma derived products * Requirement of any routine premedication for IGIV treatment * History of congenital impairment of pulmonary function * Severe liver function impairment * Severe renal function impairment or predisposition for acute renal failure * History of autoimmune haemolytic anaemia * History of diabetes mellitus * Congestive heart failure NYHA III or IV * Non-controlled arterial hypertension * History of DVT or thrombotic complications with IGIV treatment * Known infection with HIV, HCV or HBV * Treatment with steroids, immunosuppressive or immunomodulatory drugs * Planned vaccination during study period * Pregnant or nursing woman