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

NCT04132050 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2025-08-11

Study results available
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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.

Conditions

  • Idiopathic Thrombocytopenic Purpura

Interventions

DRUG

R788

Oral administration

DRUG

Placebo

Oral administration

Sponsors & Collaborators

  • Kissei Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yoshitaka Shimizu · Kissei Pharmaceutical Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-24
Primary Completion
2021-12-21
Completion
2023-09-25

Countries

  • Japan

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04132050 on ClinicalTrials.gov