NCT00162006CompletedPhase 2
Prospective Open-Label Study of the Efficacy and Safety of Immune Globulin Intravenous (Human), 10% TVR Solution in Adult Subjects With Chronic Idiopathic Thrombocytopenic Purpura
Baxalta now part of Shire11 sites in 4 countries28 target enrollmentStarted: January 13, 2003Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 28
- Locations
- 11
- Primary Endpoint
- Subjects Who Qualify As Treatment Responders
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Subjects Who Qualify As Treatment Responders
Time Frame: 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 Outcomes
- 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))
- Duration of platelet response(Day 2)
- Time to achieve a platelet count > 50 x 109/L(Screening visit)
- Time to achieve a platelet count > 50 x 109/L(Day 1 (initiation of treatment))
- Time to achieve a platelet count > 50 x 109/L(Day 2)
- Time to achieve a platelet count > 50 x 109/L(Day 5)
- Time to achieve a platelet count > 50 x 109/L(Day 8)
- Time to achieve a platelet count > 50 x 109/L(Day 11)
- Time to achieve a platelet count > 50 x 109/L(Day 22)
- Time to achieve a platelet count > 50 x 109/L(Day 15)
- Duration of platelet response(Screening visit)
- Duration of platelet response(Day 1 (initiation visit))
- Duration of platelet response(Day 5)
- Duration of platelet response(Day 8)
- Duration of platelet response(Day 11)
- Duration of platelet response(Day 15)
- Duration of platelet response(Day 22)
- Maximum Platelet Count(Screening visit)
- Maximum Platelet Count(Day 1 (initiation visit))
- Maximum Platelet Count(Day 2)
- Maximum Platelet Count(Day 5)
- Maximum Platelet Count(Day 8)
- Maximum Platelet Count(Day 11)
- Maximum Platelet Count(Day 15)
- Maximum Platelet Count(Day 22)
Investigators
Study Sites (11)
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