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

Conditions

Idiopathic Thrombocytopenic Purpura

Keywords

ITP

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

Heng Mei, Xiaofan Liu, Yan Li, Hu Zhou, Ying Feng et al. (27 authors)

Blood2025-11-03

10.1182/blood-2025-4812

Hetrombopag for patients with persistent primary immune thrombocytopenia: a post hoc analysis of a multicenter, randomized phase Ⅲ trial.

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, Shen X, Jin J, Luo J, Zeng Y, Zhou X, Xia R, Jiang Z, Bai Y, Wang L, Niu T, Yang R, Hu Y.

2025-10-07

10.1016/j.rpth.2025.103205

Switching from Eltrombopag to Hetrombopag in Patients with Primary Immune Thrombocytopenia (ITP): Post-Hoc Analysis of a Multicenter, Randomized Phase III Trial

Yu Hu, Renchi Yang, Ting Niu, Heng Mei, Xiaofan Liu et al. (29 authors)

Blood2022-11-151 citations

10.1182/blood-2022-162945

Safety and efficacy of hetrombopag in patients with chronic immune thrombocytopenia: a single-arm, open-label, multi-center phase 1 study.

Mei H, Chen X, Zhou J, Luo J, Shi Q, Liu J, Wu D, Chen G, Tai Y, Xiong J, Zou J, Hu Y.

2022-01-012 citations

10.21037/atm-21-4361

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.

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.

2021-12-158 citations

10.1111/jth.15602

A multicenter, randomized phase III trial of hetrombopag: a novel thrombopoietin receptor agonist for the treatment of immune thrombocytopenia.

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.

2021-02-2547 citations

10.1186/s13045-021-01047-9

Interventions

DRUGHetrombopag Olamine

once daily

DRUGmatching placebo

once daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

1. Confirmed diagnosis of ITP ≥6 months;Platelets \<30×109/L. 2. No evidence of other causes of thrombocytopenia. 3. Subjects who are refractory or have relapsed after at least one prior ITP therapy. 4. Previous therapy for ITP including rescue must have been completed at least 2 weeks prior to randomization. 5. Subjects treated with maintenance immunosuppressive therapy must be receiving a dose that has been stable for at least 1 month. 6. PT result no exceed normal by more than ±3s,APTT result no exceed normal by more than ±10s. 7. Signed informed consent.

Exclusion criteria

1. Patients with any prior history of arterial or venous thrombosis，or diagnosis as Thrombophilia. 2. Subjects diagnosed with tumor. 3. 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. 4. Female subjects who are nursing or pregnant at screening or pre-dose on baseline. 5. Subjects who have previously received eltrombopag or any other thrombopoietin receptor agonist within 30 days . 6. 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. 7. 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. 8. 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) 9. The subject has participated in other clinical trial within the 3 months prior to randomization.

Design outcomes

Primary

Measure	Time frame
the proportion of patients with a platelet count ≥50×109/L after Day 57.	Baseline to Week 8

Countries

China

Outcome results

None listed