Evidence map›Paper›PMID 33632264›Full record

Trial reportJournal of hematology & oncology2021

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

Heng Mei, Xiaofan Liu, Yan Li, Hu Zhou, Ying Feng, Guangxun Gao, Peng Cheng, Ruibin Huang, Linhua Yang, Jianda Hu and 29 more

4 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of hematology & oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 43 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed, 3 pooled it
6.9field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03222843 phase3completednot on this map

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

TypeinterventionalSponsorJiangsu HengRui Medicine Co., Ltd.Ran2017 to 2021Enrolled424ConditionsIdiopathic Thrombocytopenic PurpuraArmsHetrombopag Olamine, matching placebo
NCT05018936 phase2 / phase3withdrawnnot on this map

Efficacy and Safety of Hetrombopag in Non-severe Aplastic Anemia: a Prospective Single Arm Study

TypeinterventionalSponsorPeking Union Medical College HospitalRan2021 to 2023Enrolled0ConditionsAplastic Anemia, Drug EffectArmsHetrombopag
NCT05024877 phase2 / phase3unknown statusnot on this map

The Efficacy and Safety of Hetrombopag for Low/Intermediate-1 Risk MDS With Thrombocytopenia

TypeinterventionalSponsorPeking Union Medical College HospitalRan2021 to 2023Enrolled50ConditionsMDSArmsHetrombopag, Stanozolol Tablets
NCT06745219 phase2not yet recruitingnot on this mapstarted 2025, after this paper: background citation

Herombopag for the Prevention of Radio-chemotherapy Induced Thrombocytopenia in Cervical Cancer: A Single-arm Phase II Clinical Trial

TypeinterventionalSponsorPeking University Cancer Hospital & InstituteRan2025 to 2025Enrolled30ConditionsThrombopenia, Cervical Cancer, Radiotherapy Side Effect, Chemotherapeutic ToxicityArmsherombopag
3 · Its place in the literature

Who cites it

43 citing papers in PubMed, 3 syntheses or guidelines pooled it, 71 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

39 authors at 20 institutions in 1 country.

Heng Mei *Institute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, 430022, China.
Xiaofan Liu *Thrombosis and Hemostasis Center, State Key Laboratory of Experimental Hematology, National Clinical Research Center for Hematological Disorders, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin Laboratory of Blood Disease Gene Therapy, CAMS Key Laboratory of Gene Therapy for Blood Diseases, Tianjin, 300020, China.
Yan Li *Department of Hematology, Institute of Hematology, West China Hospital, Sichuan University, Chengdu, 610041, Sichuan, China.
Hu ZhouDepartment of Hematology, Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China.
Ying FengDepartment of Hematopathology, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
Guangxun GaoThe Blood Internal Medicine, The First Affiliated Hospital of Air Force Medical University, Xi'an, China.
Peng ChengHematology Department, The First Affiliated Hospital of Guangxi Medical University, Nanning, China.
Ruibin HuangHematology Department, The First Affiliated Hospital of Nanchang University, Nanchang, China.
Linhua YangDepartment of Hematology, The Second Hospital of Shanxi Medical University, Taiyuan, China.
Jianda HuFujian Medical University Union Hospital, Fuzhou, China.
Ming HouDepartment of Hematology, Qilu Hospital, Shandong University, Jinan, China.
Yazhou YaoHematology Department, Baoji Central Hospital, Baoji, China.
Li LiuDepartment of Hematopathology, The Second Affiliated Hospital of Air Force Medical University, Xi'an, China.
Yi WangDepartment of Hematopathology, Shaanxi Provincial People's Hospital, Xi'an, China.
Depei WuHematology Department, The First Affiliated Hospital of Soochow University, Suzhou, China.
Liansheng ZhangHematology Department, Lanzhou University Second Hospital, Lanzhou, China.
Changcheng ZhengHematology Department, The First Affiliated Hospital of USTC, Hefei, China.
Xuliang ShenDepartment of Hematology, Heping Hospital Affiliated To Changzhi Medical College, Changzhi, China.
Qi HuDepartment of Hematology, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai, China.
Jing LiuThe Third Xiangya Hospital of Central South University, Changsha, China.
Jie JinDepartment of Hematology, The First Affiliated Hospital, Zhejiang University College of Medicine, Hangzhou, China.
Jianmin LuoDepartment of Hematology, The Second Hospital of Hebei Medical University, Shijiazhuang, China.
Yun ZengDepartment of Hematology, First Affiliated Hospital of Kunming Medical University, KunMing, China.
Sujun GaoThe First Hospital of Jilin University, Changchun, China.
Xiaohui ZhangDepartment of Hematology, Peking University People's Hospital, Beijing, China.
Xin ZhouHematology Department, Wuxi People's Hospital, Wuxi, China.
Qingzhi ShiHematology Department, The Second Affiliated Hospital of Nanchang University, Nanchang, China.
Ruixiang XiaHematology Department, The First Affiliated Hospital of Anhui Medical University, Hefei, China.
Xiaobao XieHematology Department, The First People's Hospital of Changzhou, Changzhou, China.
Zhongxing JiangDepartment of Hematology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
Li GaoDepartment of Hematology, The Second Affiliated Hospital of Military Medical University PLA, Chongqing, China.
Yuansong BaiHematology and Oncology, China-Japan Union Hospital of Jilin University, Changchun, China.
Yan LiHematology Department, The First Hospital of China Medical University, Shenyang, China.
Junye XiongClinical Research & Development, Jiangsu Hengrui Medicine Co., Ltd, Shanghai, China.
Runzi LiClinical Research & Development, Jiangsu Hengrui Medicine Co., Ltd, Shanghai, China.
Jianjun ZouClinical Research & Development, Jiangsu Hengrui Medicine Co., Ltd, Shanghai, China.
Ting NiuDepartment of Hematology, Institute of Hematology, West China Hospital, Sichuan University, Chengdu, 610041, Sichuan, China. dr_huyu@126.com.
Renchi YangThrombosis and Hemostasis Center, State Key Laboratory of Experimental Hematology, National Clinical Research Center for Hematological Disorders, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin Laboratory of Blood Disease Gene Therapy, CAMS Key Laboratory of Gene Therapy for Blood Diseases, Tianjin, 300020, China. rcyang@ihcams.ac.cn.
Yu HuInstitute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, 430022, China. tingniu@sina.com.ORCID 0000-0002-2815-4568
Jiangsu Hengrui Medicine (China) · CNSichuan University · CNUnion Hospital · CNChinese Academy of Medical Sciences & Peking Union Medical College · CNNanchang University · CNShanxi Medical University · CNAir Force Medical University · CNAnhui Medical University · CNBaoji City Central Hospital · CNCentral South University · CNChangzhi Medical College · CNDalian Medical University · CNFirst Affiliated Hospital of Zhengzhou University · CNFirst Affiliated Hospital Zhejiang University · CNFujian Medical University · CNGuangxi Medical University · CNHebei Medical University · CNJilin University · CNKunming Medical University · CNLanzhou University Second Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHetrombopag, a novel thrombopoietin receptor agonist, has been found in phase I studies to increase platelet counts and reduce bleeding risks in adults with immune thrombocytopenia (ITP). This phase III study aimed to evaluate the efficacy and safety of hetrombopag in ITP patients.

methodsPatients who had not responded to or had relapsed after previous treatment were treated with an initial dosage of once-daily 2.5 or 5 mg hetrombopag (defined as the HETROM-2.5 or HETROM-5 group) or with matching placebo in a randomized, double-blind, 10-week treatment period. Patients who received placebo and completed 10 weeks of treatment switched to receive eltrombopag, and patients treated with hetrombopag in the double-blind period continued hetrombopag during the following open-label 14-week treatment. The primary endpoint was the proportion of responders (defined as those achieving a platelet count of ≥ 50 × 10

resultsThe primary endpoint was achieved by significantly more patients in the HETROM-2.5 (58.9%; odds ratio [OR] 25.97, 95% confidence interval [CI] 9.83-68.63; p < 0.0001) and HETROM-5 (64.3%; OR 32.81, 95% CI 12.39-86.87; p < 0.0001) group than in the Placebo group (5.9%). Hetrombopag was also superior to placebo in achieving a platelet response and in reducing the bleeding risk and use of rescue therapy throughout 8 weeks of treatment. The durable platelet response to hetrombopag was maintained throughout 24 weeks. The most common adverse events were upper respiratory tract infection (42.2%), urinary tract infection (17.1%), immune thrombocytopenic purpura (17.1%) and hematuria (15%) with 24-week hetrombopag treatment.

conclusionsIn ITP patients, hetrombopag is efficacious and well tolerated with a manageable safety profile. Trial registration Clinical trials.gov NCT03222843 , registered July 19, 2017, retrospectively registered.

Indexed as

AdultDouble-Blind MethodFemaleHumansHydrazonesMaleMiddle AgedPurpura, Thrombocytopenic, IdiopathicPyrazolonesReceptors, ThrombopoietinTreatment OutcomeYoung AdulthetrombopagHydrazonesPyrazolonesReceptors, ThrombopoietinHetrombopagImmune thrombocytopeniaPlatelet responseThrombopoietin receptor agonists

Identifiers

PMID33632264
PMCPMC7905908
OpenAlexW3133256211

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.