Phase 3 study to Evaluate the Efficacy and Safety of Avatrombopag in Japanese Adults with Chronic Immune Thrombocytopenia
- Conditions
- Chronic Immune Thrombocytopenia
- Registration Number
- jRCT2031220005
- Lead Sponsor
- Sobi, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 19
-Men and women >_18 years of age.
-Subject has a confirmed diagnosis of chronic ITP (>_12 months duration) and has had an insufficient response to a previous ITP treatment, in the opinion of the Investigator.
-Subject has an average of 2 platelet counts <30x10^9/L (no single count can be >35x10^9/L). The 2 samples must be obtained >_48 hours and <_2 weeks apart.
'-Subjects with known secondary immune thrombocytopenia (e.g., with known Helicobacter pylori-induced ITP, subjects infected with known human immunodeficiency virus [HIV] or hepatitis C virus [HCV] or subjects with known systemic lupus erythematosus). -Subjects with known inherited thrombocytopenia (e.g., MYH-9 disorders) or hereditary thrombophilic disorders (e.g., Factor V Leiden, antithrombin III deficiency).
Study & Design
- Study Type
- Interventional
- Study Design
- single assignment
- Primary Outcome Measures
Name Time Method cumulative number of weeks with platelet count >_50x10^9/L during 26 weeks of treatment in the absence of rescue therapy The cumulative number of weeks in which the platelet count is ≥50×10⁹/L
- Secondary Outcome Measures
Name Time Method Platelet response rate at Day 8 Day 8 Proportion of subjects with a platelet response ≥50×10^9/L at Day 8