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

• Status: Completed
• Trial end date: 2003-12-03
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate whether Immune Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) Solution is an effective and safe treatment in patients with chronic idiopathic thrombocytopenic purpura.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baxalta now part of Shire; Baxalta US Inc.
• Treatments: Antibodies; gamma-Globulins; Immunoglobulins; Immunoglobulins, Intravenous; Pharmaceutical Solutions; Rho(D) Immune Globulin

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