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

NCT03222843 | Completed Phase 3

• 1 other identifier: HR-TPO-III-ITP
• Study Type: interventional
• Target: 424
• Locations: 1 country
• Sites: 3

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

Conditions

Idiopathic Thrombocytopenic Purpura

Keywords

ITP

Outcome Measures

Primary Outcomes (1)

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

  Baseline to Week 8

Study Arms (4)

Arm 1

EXPERIMENTAL

oral hetrombopag at an initial dose of 2.5 mg once daily

Drug: Hetrombopag Olamine

Arm 2

EXPERIMENTAL

oral hetrombopag at an initial dose of 5 mg once daily

Drug: Hetrombopag Olamine

Arm 3

PLACEBO COMPARATOR

oral placebo at an initial dose of 2.5 mg once daily

Drug: matching placebo

Arm 4

PLACEBO COMPARATOR

oral placebo at an initial dose of 5 mg once daily

Drug: matching placebo

Interventions

Hetrombopag Olamine DRUG

once daily

Arm 1; Arm 2

matching placebo DRUG

once daily

Arm 3; Arm 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (3)

Union Hospital Tongji Medical College Huazhong University of Science and technology

Wuhan, Hubei, 430022, China

Location

West China Hospital，Sichuan University

Chengdu, Sichuan, 610041, China

Location

Hospital of Blood Diseases, Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, 300041, China

Location

Related Publications (2)

• 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.

  PMID: 34821020 DERIVED

• 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.

  PMID: 33632264 DERIVED

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2017
• First Posted: July 19, 2017
• Study Start: June 30, 2017
• Primary Completion: November 11, 2019
• Study Completion: January 7, 2021
• Last Updated: August 3, 2022

Record last verified: 2017-07

Locations

CN (3)