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

Phase 3CompletedNCT04132050

Kissei Pharmaceutical Co., Ltd.34 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Idiopathic Thrombocytopenic Purpura

Interventions

R788DRUG

Oral administration

PlaceboDRUG

Oral administration

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

Research Site

Multiple Locations, Japan

Outcomes

Primary Outcomes

Achievement Rate of Stable Platelet Response

The percentage of subjects who achieved stable platelet response (defined as a platelet count of ≥50000/μL at 4 or more of the 6 visits from Weeks 14 to 24)

Time frame: 24 weeks (Period I)

Data from ClinicalTrials.gov

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