Efficacy and Safety Study of a 10% Triple Virally Reduced Intravenous Immune Globulin Solution in Adult Subjects With Chronic Idiopathic Thrombocytopenic Purpura

Exclusion Criteria

• •Serum values of ALT, AST, alkaline phosphatase, and total bilirubin exceeding 2.5 times the upper limit of normal at screening
• •Renal dysfunction defined as serum creatinine greater than or equal to 2 mg/dL at screening
• •Underlying other autoimmune or lymphoproliferative disorder
• •Uncontrolled hypertension
• •Cardiac insufficiency NYHA III and IV, coronary heart disease (CHD) NYHA III and IV
• •Malignancy or history of malignancy
• •Documented selective IgA deficiency (\<= 10 mg/dL)
• •Treatment with another investigational drug in the four weeks prior to study entry or current treatment with another investigational product
• •History of severe adverse reactions to blood and/or blood products
• •Pregnancy or lactation
• •Positivity for HIV, or HCV antibodies, or HBsAg
• •History of unresponsiveness to IVIG defined as a peak increment in platelet count \<= 20,000/µL coincident with the last IVIG treatment course prior to study entry