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

Primary Purpose

Idiopathic Thrombocytopenic Purpura

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Hetrombopag Olamine

matching placebo

About this trial

This is an interventional treatment trial for Idiopathic Thrombocytopenic Purpura focused on measuring ITP

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.
Subjects treated with maintenance immunosuppressive therapy must be receiving a dose that has been stable for at least 1 month.
PT result no exceed normal by more than ±3s,APTT result no exceed normal by more than ±10s.
Signed informed consent.

Exclusion Criteria:

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.
Subjects who have previously received eltrombopag or any other thrombopoietin receptor agonist within 30 days .
Subject has consumed aspirin, aspirin-containing compounds, salicylates, anticoagulants, quinine or non-steroidal anti-inflammatories (NSAIDs) for >3 consecutive days within 2 weeks of the study start and until the end of the study.
Any laboratory or clinical evidence for HIV infection.Any clinical history for hepatitis C infection; chronic hepatitis B infection; or any evidence for active hepatitis at the time of subject screening.
ALT> 1.5 x upper limit of normal (ULN), AST> 3 x upper limit of normal (ULN)) DBLI> 1.2 x upper limit of normal (ULN),Scr> 1.2 x upper limit of normal (ULN)
The subject has participated in other clinical trial within the 3 months prior to randomization.

Sites / Locations

Union Hospital Tongji Medical College Huazhong University of Science and technology
West China Hospital，Sichuan University
Hospital of Blood Diseases, Chinese Academy of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm 1

Arm 2

Arm 3

Arm 4

Arm Description

oral hetrombopag at an initial dose of 2.5 mg once daily

oral hetrombopag at an initial dose of 5 mg once daily

oral placebo at an initial dose of 2.5 mg once daily

oral placebo at an initial dose of 5 mg once daily

Outcomes

Primary Outcome Measures

the proportion of patients with a platelet count ≥50×109/L after Day 57.

Secondary Outcome Measures

Full Information

NCT ID

NCT03222843

First Posted

July 18, 2017

Last Updated

August 2, 2022

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03222843

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

June 30, 2017 (Actual)

Primary Completion Date

November 11, 2019 (Actual)

Study Completion Date

January 7, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Idiopathic Thrombocytopenic Purpura

Keywords

ITP

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

424 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Description

oral hetrombopag at an initial dose of 2.5 mg once daily

Arm Title

Arm 2

Arm Type

Experimental

Arm Description

oral hetrombopag at an initial dose of 5 mg once daily

Arm Title

Arm 3

Arm Type

Placebo Comparator

Arm Description

oral placebo at an initial dose of 2.5 mg once daily

Arm Title

Arm 4

Arm Type

Placebo Comparator

Arm Description

oral placebo at an initial dose of 5 mg once daily

Intervention Type

Drug

Intervention Name(s)

Hetrombopag Olamine

Intervention Description

once daily

Intervention Type

Drug

Intervention Name(s)

matching placebo

Intervention Description

once daily

Primary Outcome Measure Information:

Title

the proportion of patients with a platelet count ≥50×109/L after Day 57.

Time Frame

Baseline to Week 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Subjects treated with maintenance immunosuppressive therapy must be receiving a dose that has been stable for at least 1 month. PT result no exceed normal by more than ±3s,APTT result no exceed normal by more than ±10s. Signed informed consent. Exclusion Criteria: 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. Subjects who have previously received eltrombopag or any other thrombopoietin receptor agonist within 30 days . Subject has consumed aspirin, aspirin-containing compounds, salicylates, anticoagulants, quinine or non-steroidal anti-inflammatories (NSAIDs) for >3 consecutive days within 2 weeks of the study start and until the end of the study. Any laboratory or clinical evidence for HIV infection.Any clinical history for hepatitis C infection; chronic hepatitis B infection; or any evidence for active hepatitis at the time of subject screening. ALT> 1.5 x upper limit of normal (ULN), AST> 3 x upper limit of normal (ULN)) DBLI> 1.2 x upper limit of normal (ULN),Scr> 1.2 x upper limit of normal (ULN) The subject has participated in other clinical trial within the 3 months prior to randomization.

Facility Information:

Facility Name

Union Hospital Tongji Medical College Huazhong University of Science and technology

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430022

Country

China

Facility Name

West China Hospital，Sichuan University

City

Chengdu

State/Province

Sichuan

ZIP/Postal Code

610041

Country

China

Facility Name

Hospital of Blood Diseases, Chinese Academy of Medical Sciences

City

Tianjin

State/Province

Tianjin

ZIP/Postal Code

300041

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

34821020

Citation

Mei H, Liu X, Li Y, Zhou H, Feng Y, Gao G, Cheng P, Huang R, Yang L, Hu J, Hou M, Yao Y, Liu L, Wang Y, Wu D, Zhang L, Zheng C, Shen X, Hu Q, Liu J, Jin J, Luo J, Zeng Y, Gao S, Zhang X, Zhou X, Shi Q, Xia R, Xie X, Jiang Z, Gao L, Bai Y, Li Y, Xiong J, Li R, Zou J, Niu T, Yang R, Hu Y. Dose tapering to withdrawal stage and long-term efficacy and safety of hetrombopag for the treatment of immune thrombocytopenia: Results from an open-label extension study. J Thromb Haemost. 2022 Mar;20(3):716-728. doi: 10.1111/jth.15602. Epub 2021 Dec 15.

Results Reference

derived

PubMed Identifier

33632264

Citation

Mei H, Liu X, Li Y, Zhou H, Feng Y, Gao G, Cheng P, Huang R, Yang L, Hu J, Hou M, Yao Y, Liu L, Wang Y, Wu D, Zhang L, Zheng C, Shen X, Hu Q, Liu J, Jin J, Luo J, Zeng Y, Gao S, Zhang X, Zhou X, Shi Q, Xia R, Xie X, Jiang Z, Gao L, Bai Y, Li Y, Xiong J, Li R, Zou J, Niu T, Yang R, Hu Y. A multicenter, randomized phase III trial of hetrombopag: a novel thrombopoietin receptor agonist for the treatment of immune thrombocytopenia. J Hematol Oncol. 2021 Feb 25;14(1):37. doi: 10.1186/s13045-021-01047-9.

Results Reference

derived

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

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