Completed

Multicentre, Randomised Phase III Study of the Efficacy and Safety of Hetrombopag Olamine in Idiopathic Thrombocytopenic Purpura (ITP) Patient

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What is being tested

Hetrombopag Olamine

+ matching placebo
Drug
Who is being recruted

Idiopathic Thrombocytopenic Purpura

Over 18 Years
+16 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-Controlled
Phase 3
Interventional
Study Start: June 2017

See protocol details

Summary

Principal SponsorJiangsu HengRui Medicine Co., Ltd.
Last updated: August 3, 2022
Sourced from a government-validated database.Claim as a partner
Study start date: June 30, 2017Actual 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 
Principal SponsorJiangsu HengRui Medicine Co., Ltd.
Last updated: August 3, 2022
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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Participants, researchers, outcome assessors, and care providers do not know which treatment is being given. This is the most complete way to prevent bias and keep the study as neutral as possible.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Idiopathic Thrombocytopenic Purpura
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 technologyWuhan, ChinaSee the location
Suspended
West China Hospital，Sichuan UniversityChengdu, China
Suspended
Hospital of Blood Diseases, Chinese Academy of Medical SciencesTianjin, China
Completed3 Study Centers