Phase 3
N=34
A Clinical Study in Patients With Chronic Idiopathic Thrombocytopenic Purpura in R788
Idiopathic Thrombocytopenic Purpura
Bottom Line
View on ClinicalTrials.gov: NCT04132050 ↗Enrolled (actual)
34
Serious AEs
16.4%
Results posted
Aug 2025
Primary outcome: Primary: Achievement Rate of Stable Platelet Response — 36.4; 0.0 Percentage of participants — p=0.030
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- R788 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Kissei Pharmaceutical Co., Ltd.
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Achievement Rate of Stable Platelet Response |
36.4; 0.0 | 0.030 sig |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT04132050). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.