Evidence map›Paper›PMID 35284778›Full record

ArticleResearch and practice in thrombosis and haemostasis2022

Prophylactic emicizumab for hemophilia A in the Asia-Pacific region: A randomized study (HAVEN 5).

Renchi Yang, Shujie Wang, Xuefeng Wang, Jing Sun, Ampaiwan Chuansumrit, Jianfeng Zhou, Christophe Schmitt, Wanling Hsu, Jeffrey Xu, Lindong Li and 2 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Research and practice in thrombosis and haemostasis, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03315455 (A Randomized, Multicenter, Open-Label, Phase III Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Prophylactic Emicizumab Versus No Prophylaxis in Hemophilia A Patients), which is not on this map. Cited by 40 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 1 pooled it
9.8field-weighted citation impact, top 1% 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.

NCT03315455 phase3completednot on this map

A Randomized, Multicenter, Open-Label, Phase III Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Prophylactic Emicizumab Versus No Prophylaxis in Hemophilia A Patients

TypeinterventionalSponsorHoffmann-La RocheRan2018 to 2025Enrolled85ConditionsHemophilia AArmsEmicizumab
3 · Its place in the literature

Who cites it

40 citing papers in PubMed, 1 synthesis or guideline pooled it, 66 citations in OpenAlex.

  1. [Chinese guidelines on the treatment of hemophilia (2025)].Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi · 2025
    Guideline
  2. Trial
  3. Trial
  4. Trial
  5. Emicizumab dose up-titration in case of suboptimal bleeding control in people with haemophilia A.Haemophilia : the official journal of the World Federation of Hemophilia · 2023
    Trial
  6. Article
  7. Article
  8. Observational
  9. Non-Factor Therapies in Haemophilia: The Era of Factor VIII Mimetics and Targeted Rebalancing Agents.Transfusion medicine and hemotherapy : offizielles Organ der Deutschen Gesellschaft fur Transfusionsmedizin und Immunhamatologie · 2026
    Review
  10. Article
  11. Review
  12. Article
  13. Article
  14. Article
  15. NXT007 enhancesResearch and practice in thrombosis and haemostasis · 2025
    Article
  16. Emicizumab in Children with Severe Hemophilia A.Indian journal of pediatrics · 2025
    Observational
  17. Article
  18. Article
  19. Review
  20. 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

12 authors at 9 institutions in 4 countries.

Renchi YangInstitute of Haematology & Blood Diseases Hospital Chinese Academy of Medical Sciences Tianjin China.ORCID https://orcid.org/0000-0003-3741-8518
Shujie WangPeking Union Medical College Hospital Beijing China.
Xuefeng WangRuijin Hospital Shanghai Jiao Tong University School of Medicine Shanghai China.
Jing SunNanfang Hospital Southern Medical University Guangzhou China.
Ampaiwan ChuansumritFaculty of Medicine Ramathibodi Hospital Mahidol University Bangkok Thailand.ORCID https://orcid.org/0000-0003-1230-1591
Jianfeng ZhouTongji Hospital Tongji Medical College Huazhong University of Science & Technology Wuhan China.
Christophe SchmittF. Hoffmann-La Roche Ltd Basel Switzerland.ORCID https://orcid.org/0000-0001-8001-5584
Wanling HsuProduct Development Oncology Roche (China) Holding Ltd Shanghai China.
Jeffrey XuProduct Development Oncology Roche (China) Holding Ltd Shanghai China.
Lindong LiProduct Development Oncology Roche (China) Holding Ltd Shanghai China.
Tiffany ChangGenentech, Inc. South San Francisco California USA.
Xielan ZhaoXiangya Hospital of Centre-South University Changsha China.
Roche (China) · CNChinese Academy of Medical Sciences & Peking Union Medical College · CNCentral South University · CNMahidol University · THNanfang Hospital · CNRoche (Switzerland) · CHShanghai Jiao Tong University · CNSpark Therapeutics (United States) · USTongji Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Emicizumab is a subcutaneously administered humanized, bispecific, monoclonal antibody approved for prophylaxis in people with hemophilia A. Methods: HAVEN 5 (NCT03315455) is a randomized, open-label, phase 3 study of individuals aged ≥12 years with severe hemophilia A without factor VIII (FVIII) inhibitors, or hemophilia A of any severity with FVIII inhibitors, across the Asia-Pacific region. Participants were randomly assigned (2:2:1) to receive emicizumab 1.5 mg/kg once weekly (arm A), emicizumab 6 mg/kg every 4 weeks (arm B), or no prophylaxis (arm C). The primary end point was annualized bleeding rate (ABR) for treated bleeds; ABRs were compared between people receiving emicizumab prophylaxis versus those with no prophylaxis. Secondary end points included ABR for treated target joint bleeds. Safety was also evaluated. Results: From April 26, 2018, to January 4, 2019, 70 of 76 screened participants were enrolled and randomized (arm A, n = 29; arm B, n = 27; arm C, n = 14). ABRs (95% confidence interval) for treated bleeds and treated target joint bleeds, respectively, were: arm A, 1.0 (0.53-1.85) and 0.4 (0.18-1.09); arm B, 1.0 (0.50-1.84) and 0.3 (0.12-0.85); arm C, 27.0 (13.29-54.91) and 8.6 (3.15-23.42). The most common adverse event, upper respiratory tract infection, was reported for 14 of 56 (25.0%; emicizumab) and 2 of 14 (14.3%; no prophylaxis) participants. No thrombotic events, thrombotic microangiopathies, or deaths were reported. Conclusion: Emicizumab 1.5 mg/kg once weekly and 6 mg/kg every 4 weeks demonstrated bleed control in this study population, was well tolerated, and could improve use of prophylaxis in people with hemophilia A.

Indexed as

clinical trialsemicizumabfactor VIIIhemophilia Aprophylaxisrandomized

Identifiers

PMID35284778
PMCPMC8902287
OpenAlexW4220844694

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.