Completed

A Phase III,Multicentre, Randomized, Double-Blind and Open-Label Study to Evaluate the Safety and Efficacy of Hetrombopag Olamine in Patients With Idiopathic Thrombocytopenic Purpura

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What is being tested

Hetrombopag Olamine

+ matching placebo

Drug
Who is being recruted

Cytopenia+15

+ Autoimmune Diseases

+ Blood Coagulation Disorders

Over 18 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: June 2017
See protocol details

Summary

Principal SponsorJiangsu HengRui Medicine Co., Ltd.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 30, 2017

Actual date on which the first participant was enrolled.

A multicentre, randomised, double-blind,4-stages phase III study enrolled 414 patients with chronic, previously treated ITP. Dosage could be adjusted (2.5\~.75 mg/day) to maintain platelet counts 50\~250×109/L

Official TitleA Phase III,Multicentre, Randomized, Double-Blind and Open-Label Study to Evaluate the Safety and Efficacy of Hetrombopag Olamine in Patients With Idiopathic Thrombocytopenic Purpura
NCT03222843
Principal SponsorJiangsu HengRui Medicine Co., Ltd.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

424 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

CytopeniaAutoimmune DiseasesBlood Coagulation DisordersBlood Platelet DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhageHemorrhagic DisordersImmune System DiseasesPathologic ProcessesPurpuraPurpura, ThrombocytopenicSigns and SymptomsSkin ManifestationsPathological Conditions, Signs and SymptomsThrombocytopeniaPurpura, Thrombocytopenic, IdiopathicThrombotic Microangiopathies

Criteria

7 inclusion criteria required to participate
Confirmed diagnosis of ITP ≥6 months;Platelets <30×109/L.
No evidence of other causes of thrombocytopenia.
Subjects who are refractory or have relapsed after at least one prior ITP therapy.
Previous therapy for ITP including rescue must have been completed at least 2 weeks prior to randomization.
Show More Criteria
9 exclusion criteria prevent from participating
Patients with any prior history of arterial or venous thrombosis，or diagnosis as Thrombophilia.
Subjects diagnosed with tumor.
Have pre-existing cardiac disease within the last 3 months.No arrhythmia known to increase the risk of thrombolic events (e.g. atrial fibrillation), or patients with a Corrected QT interval (QTc) >450msec or QTc >480 for patients with a Bundle Branch Block.
Female subjects who are nursing or pregnant at screening or pre-dose on baseline.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
oral hetrombopag at an initial dose of 2.5 mg once daily

Group II

Experimental
oral hetrombopag at an initial dose of 5 mg once daily

Group III

Placebo
oral placebo at an initial dose of 2.5 mg once daily

Group IV

Placebo
oral placebo at an initial dose of 5 mg once daily

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Suspended

Union Hospital Tongji Medical College Huazhong University of Science and technology

Wuhan, ChinaOpen Union Hospital Tongji Medical College Huazhong University of Science and technology in Google Maps
Suspended

West China Hospital，Sichuan University

Chengdu, China
Suspended

Hospital of Blood Diseases, Chinese Academy of Medical Sciences

Tianjin, China
Completed3 Study Centers