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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04132050
Other study ID # R788-1301
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date December 24, 2019
Est. completion date September 25, 2023

Study information

Verified date December 2023
Source Kissei Pharmaceutical Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
R788
Oral administration
Placebo
Oral administration

Locations

Country Name City State
Japan Research Site Multiple Locations

Sponsors (1)

Lead Sponsor Collaborator
Kissei Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

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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