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Completed

NCT Number: NCT04132050

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

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.

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Key information

Conditions

Idiopathic Thrombocytopenic Purpura Autoimmune Diseases Blood Coagulation Disorders Blood Platelet Disorders Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Purpura Purpura, Thrombocytopenic Purpura, Thrombocytopenic, Idiopathic Signs and Symptoms Skin Manifestations Thrombocytopenia Thrombotic Microangiopathies

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site

Multiple Locations, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

R788

Drug

Oral administration

Placebo

Drug

Oral administration

Primary outcomes

  1. Achievement Rate of Stable Platelet Response

    Time frame: 24 weeks (Period I)

    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)

Other outcomes

  1. Duration of Platelet Response

    Time frame: R788 treatment period (maximum duration of exposure was 1184 days)

    Period from the first measurement day on which a platelet count of ≥50000/μL for at least 28 consecutive days was achieved to the first measurement day on which platelet count fell below 50000/μL for at least 28 consecutive days

Sponsors and collaborators

Lead sponsor

Kissei Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2023
First posted
Oct 18, 2019
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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