Status:
COMPLETED
A Clinical Study in Patients With Chronic Idiopathic Thrombocytopenic Purpura in R788
Lead Sponsor:
Kissei Pharmaceutical Co., Ltd.
Conditions:
Idiopathic Thrombocytopenic Purpura
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to investigate the efficacy, safety and pharmacokinetics of R788 compared with placebo, and to investigate the safety and efficacy of long term dosing of R788 in patients ...
Eligibility Criteria
Inclusion
- Japanese patients
- Patients diagnosed with idiopathic thrombocytopenic purpura at least 6 months before acquisition of consent
- Patients with a platelet count averages \<30000/μL during screening period. Each platelet count should not exceed 35000/μL.
- Patients who have used and failed or who were intolerant at least 1 typical regimen for the treatment of ITP before informed consent (with or without splenectomy)
Exclusion
- Patients with thrombocytopenia associated with other disease
- Patients with autoimmune hemolytic anemia
- Patients with poorly controlled hypertension
- Patients with a history or active coagulopathy
Key Trial Info
Start Date :
December 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 25 2023
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04132050
Start Date
December 24 2019
End Date
September 25 2023
Last Update
August 11 2025
Active Locations (1)
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1
Research Site
Multiple Locations, Japan