Efficacy and Safety Study of a 10% Triple Virally Reduced Intravenous Immune Globulin Solution in Adult Subjects With Chronic Idiopathic Thrombocytopenic Purpura
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Study Design
Outcome Measures
Primary Outcome Measures
- 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
- 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]
- Time to achieve a platelet count > 50 x 109/L [Day 29 (study termination visit)]
- Duration of platelet response [Screening visit]
- Duration of platelet response [Day 1 (initiation visit)]
- Duration of platelet response [Day 2]
- 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]
- Duration of platelet response [Day 29 (study termination visit)]
- 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]
- Maximum Platelet Count [Day 29 (study termination visit)]
- Number of Adverse Experiences [Throughout the study period of approximately 11 months]
Eligibility Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Brno | Czechia | |||
2 | Hradec Králové | Czechia | |||
3 | Olomouc | Czechia | |||
4 | Prague | Czechia | |||
5 | Giessen | Germany | |||
6 | Halle/Saale | Germany | |||
7 | Debrecen | Hungary | |||
8 | Györ | Hungary | |||
9 | Szeged | Hungary | |||
10 | Szombathely | Hungary | |||
11 | Lodz | Poland |
Sponsors and Collaborators
- Baxalta now part of Shire
Investigators
- Study Director: Study Director, Takeda
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 160002