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

Idiopathic Thrombocytopenic Purpura Clinical Trial

Official title:

A Phase III Study in Patients With Chronic Idiopathic Thrombocytopenic Purpura in R788

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04132050
• Other study ID #: R788-1301
• Status: Completed
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Idiopathic Thrombocytopenic Purpura
• Purpura
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic

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