Idiopathic Thrombocytopenic Purpura Clinical Trial
Official title:
A Phase III Study in Patients With Chronic Idiopathic Thrombocytopenic Purpura in R788
Verified date | December 2023 |
Source | Kissei Pharmaceutical Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 34 |
Est. completion date | September 25, 2023 |
Est. primary completion date | December 21, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Japan | Research Site | Multiple Locations |
Lead Sponsor | Collaborator |
---|---|
Kissei Pharmaceutical Co., Ltd. |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of patients with stable platelet response | Percentage of patients with a stable platelet response by Week 24 defined as a platelet count of = 50000/µL on at least 4 of 6 visits between Week 14 to Week 24 | 24 weeks | |
Secondary | Percentage of patients with overall response | Percentage of patients with a platelet count =50000/µL on at least 1 of 6 visits from Week 2 to Week 12 | 12 weeks | |
Secondary | Duration of maintained platelet count | Duration of maintained platelet count since first achievement of a platelet count =50000/µL after administration of the study drug | 52 weeks | |
Secondary | Percentage of patients with a platelet count =50000/µL | Percentage of patients with a platelet count =50000/µL at the specified evaluation time point | Every 2 weeks up to Week 24, every 4 weeks up to Week 52 and every 8 weeks up to 3 years | |
Secondary | Percentage of patients with a platelet count increase =20000/µL above baseline and =30000/µL | Percentage of patients with a platelet count increase =20000/µL above baseline and =30000/µL at the specified evaluation time point | Every 2 weeks up to Week 24, every 4 weeks up to Week 52 and every 8 weeks up to 3 years |
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