Efficacy and Safety Study of a 10% Triple Virally Reduced Intravenous Immune Globulin Solution in Adult Subjects With Chronic Idiopathic Thrombocytopenic Purpura
Phase 2
Completed
- Conditions
- Immune Thrombocytopenic Purpura (ITP)
- Registration Number
- NCT00162006
- Lead Sponsor
- Baxalta now part of Shire
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Subjects Who Qualify As Treatment Responders Baseline thru Day 15 post treatment Subjects who i) had at least one platelet count of ≥50 x 109/L prior to Day 15 and ii) did not require a booster dose prior to Day 15, where Day 15 refers to the fifteenth day after initiation of treatment (Day 1). Otherwise, the subject is a non-responder.
- Secondary Outcome Measures
Name Time Method Time to achieve a platelet count > 50 x 109/L Day 29 (study termination visit) Duration of platelet response Day 29 (study termination visit) Number of Adverse Experiences Throughout the study period of approximately 11 months Maximum Platelet Count Day 29 (study termination visit)