Overview

A Clinical Study in Patients With Chronic Idiopathic Thrombocytopenic Purpura in R788

Status:
Active, not recruiting
Trial end date:
2023-01-01
Target enrollment:
0
Participant gender:
All
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 with chronic idiopathic thrombocytopenic purpura.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Kissei Pharmaceutical Co., Ltd.
Criteria
Inclusion Criteria:

- 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 Criteria:

- Patients with thrombocytopenia associated with other disease

- Patients with autoimmune hemolytic anemia

- Patients with poorly controlled hypertension

- Patients with a history or active coagulopathy