A Clinical Study in Patients with Chronic Idiopathic Thrombocytopenic Purpura in R78
Phase 3
Completed
- Conditions
- Idiopathic Thrombocytopenic Purpura
- Registration Number
- JPRN-jRCT2080224916
- Lead Sponsor
- Kissei Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Patients diagnosed with ITP at least 6 months before acquisition of consent
- Patients with a platelet count average of < 30000/uL during screening period and with each platelet count < 35000/uL
- Patients who have used and failed at least 1 of the typical ITP medications before informed consent
Exclusion Criteria
- Patients with thrombocytopenia associated with other diseases
- Patients with autoimmune hemolytic anemia
- Patients with poor blood pressure control
- Patients with or with a history of a history of coagulopathy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Achievement rate of stable platelet response (subjects who achieve a platelet count of >= 50000/uL on at least 4 of the 6 visits from Weeks 14 to 24 are considered as a responder and the percentage of responders will be evaluated)
- Secondary Outcome Measures
Name Time Method efficacy<br>Achievement rate of overall response (subjects who achieve a platelet count of >= 50000/uL during at least 1 of the 6 visits from Weeks 2 to 12 are considered as a responder and the percentage of responders will be evaluated)<br>efficacy<br>Duration of maintained platelet count since first achievement of a platelet count >= 50000/uL after administration of the study drug<br>efficacy<br>Achievement rate of a platelet count of >= 50000/uL at the specified evaluation time point<br>efficacy<br>Achievement rate of a platelet count of >= 30000/uL at the specified evaluation time points and platelet count increase at least 20000/uL above baseline