Efficacy and Safety Study of a 10% Triple Virally Reduced Intravenous Immune Globulin Solution in Adult Subjects With Chronic Idiopathic Thrombocytopenic Purpura
Immune Thrombocytopenic Purpura (ITP)
About this trial
This is an interventional treatment trial for Immune Thrombocytopenic Purpura (ITP) focused on measuring Chronic idiopathic thrombocytopenic purpura
Eligibility Criteria
Inclusion Criteria: Age >= 18 and <= 65 years ITP diagnosed at least 6 months prior to study entry by history, physical exam, blood count and blood smear Baseline platelet count of <= 20 x 10 to the 9th/L determined prior to administration of the study drug on the day of the first infusion No IVIG treatment for ITP during the two weeks prior to the first infusion of the study drug For females of child bearing potential, use of adequate birth control measures during study participation Written informed consent 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