Evidence map›Paper›PMID 37601010›Full record

ArticleResearch and practice in thrombosis and haemostasis2023

Romiplostim in primary immune thrombocytopenia that is persistent or chronic: phase III multicenter, randomized, placebo-controlled clinical trial in China.

Hu Zhou, Jianfeng Zhou, Depei Wu, Liping Ma, Xin Du, Ting Niu, Renchi Yang, Jing Liu, Feng Zhang, Qingzhi Shi and 22 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Research and practice in thrombosis and haemostasis, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02868099 (A Multi-center, Randomized, Placebo-controlled, Double-blinded Then Open 2 Stages Clinical Trial to Evaluate the Efficacy and Safety of Romiplostim in Adult Subjects With Persistent or Chronic Primary Immune Thrombocytopenia), which is not on this map. Cited by 7 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 2 pooled it
1.7field-weighted citation impact, top 14% 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.

NCT02868099 phase3completednot on this map

A Multi-center, Randomized, Placebo-controlled, Double-blinded Then Open 2 Stages Clinical Trial to Evaluate the Efficacy and Safety of Romiplostim in Adult Subjects With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)

TypeinterventionalSponsorKyowa Kirin China Pharmaceutical Co., Ltd.Ran2015 to 2017Enrolled203ConditionsImmune ThrombocytopeniaArmsRomiplostim, Placebo
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 2 syntheses or guidelines pooled it, 6 citations in OpenAlex.

  1. Pooled it
  2. Efficacy and Safety of Romiplostim Versus Placebo in Immune Thrombocytopenia: A Systematic Review and Meta-Analysis.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis
    Pooled it
  3. Review
  4. Review
  5. Review
  6. Article
  7. Article
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

32 authors at 20 institutions in 4 countries.

Hu ZhouHenan Cancer Hospital/The Affiliated Cancer Hospital of Zhengzhou University, Zhenzhou, China.
Jianfeng ZhouTongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology, Wuhan, China.
Depei WuThe First Affiliated Hospital of Soochow University, Suzhou, China.
Liping MaSun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.
Xin DuShenzhen Second People's Hospital, Shenzhen, China.
Ting NiuWest China Hospital, Sichuan University, Chengdu, China.
Renchi YangInstitute of Hematology & Blood Disease Hospital, Chinese Academy of Medical Science & Peking Union Medical College, Tianjin, China.
Jing LiuThe Third Xiangya Hospital of Central South University, Changsha, China.
Feng ZhangThe First Affiliated Hospital of Bengbu Medical College, Bengbu, China.
Qingzhi ShiThe Second affiliated Hospital of Nanchang University, Nanchang, China.
Xiuli WangThe Second Hospital of Jilin University, Jilin, China.
Hongmei JingPeking University Third Hospital, Beijing, China.
Junmin LiRui Jin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Xin WangShandong Provincial Hospital, Jinan, China.
Zhongguang CuiThe Affiliated Hospital of Qingdao University, Qingdao, China.
Zeping ZhouSecond Affiliated Hospital of Kunming Medical University, Kunming, China.
Ming HouQilu Hospital of Shandong University, Jinan, China.
Zonghong ShaoTianjin Medical University General Hospital, Tianjin, China.
Jie JinThe First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Wenqian LiQinghai Provincial People`s Hospital, Xining, China.
Hanyun RenPeking University First Hospital, Beijing, China.
Jianda HuFujian Medical University Union Hospital, Fuzhou, China.
Jianliang ShenNavy General Hospital PLA China, Beijing, China.
Li LiuTangdu Hospital, Xi'an, China.
Yun ZengFirst Affiliated Hospital of Kunming Medical University, Kunming, China.
Jin ZhouThe First Affiliated Hospital of Haerbin Medical University, Haerbin, China.
Xin LiuAnhui Provincial Hospital, Hefei, China.
Yunfeng ShenWuxi People`s Hospital, Wuxi, China.
Kai DingKyowa Kirin China Pharmaceutical Co, Ltd, Beijing, China.
Tadaaki TairaKyowa Kirin Co, Ltd, Tokyo, Japan.
Huacong CaiChinese Academy of Medical Sciences & Peking Union Medical College Hospital, Beijing, China.
Yongqiang ZhaoChinese Academy of Medical Sciences & Peking Union Medical College Hospital, Beijing, China.
Academy of Medical Sciences · GBKunming Medical University · CNPeking University · CNShanghai Jiao Tong University · CNAnhui Provincial Hospital · CNBengbu Medical College · CNCentral South University · CNChinese Academy of Medical Sciences & Peking Union Medical College · CNFirst Affiliated Hospital Zhejiang University · CNFujian Medical University · CNInstitute of Hematology & Blood Diseases Hospital · CNKyowa Kirin (France) · FRKyowa Kirin (Japan) · JPNanchang University · CNPLA Navy General Hospital · CNQingdao University · CNQinghai Provincial Peoples Hospital · CNSichuan University · CNSoochow University · CNSun Yat-sen University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Multiple trials have confirmed that romiplostim could increase platelet count in individuals with primary immune thrombocytopenia (ITP), but no related study has assessed Chinese patients. Objectives: To assess the effectiveness of romiplostim as a second-line treatment of persistent or chronic ITP in Chinese adults. Methods: This phase III multicenter, randomized, placebo-controlled, double-blind, then open-label clinical trial (NCT02868099, CTR20150395) was conducted at 28 investigational sites in China. The patients were randomly assigned (3:1) to romiplostim (starting and maximum doses of 1 and 10 μg/kg, respectively) or placebo for 9 weeks (double-blind period), followed by the open-label period (both groups administered romiplostim) to week 22. The primary endpoint was the time (in weeks) during which platelet counts were ≥50 × 10 Results: In this study, 202 patients (romiplostim, Conclusion: Romiplostim significantly increased the time with maintained platelet response in patients with persistent or chronic ITP in comparison with placebo. No new safety signal was observed. Trial registration: ClinicalTrials.gov, NCT02868099. www.chinadrugtrials.org.cn/clinicaltrials.searchlist.dhtml, CTR20150395.

Indexed as

primary immune thrombocytopeniarandomized controlled trialromiplostimthrombopoietin receptor

Identifiers

PMID37601010
PMCPMC10439391
OpenAlexW4377861238

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.