Recombinant Single-chain Factor VIII (rVIII-SingleChain) in Chinese Participants With Hemophilia A Previously Treated With FVIII Products

Last updated: April 22, 2026
Sponsor: CSL Behring
Overall Status: Active - Not Recruiting

Phase

3

Condition

Hemophilia

Treatment

Recombinant single-chain factor VIII (rVIII-SingleChain)

Clinical Study ID

NCT06738485
CSL627_3003
2023-001026-34
  • Ages < 65
  • Male

Study Summary

For bridging the available global clinical data of rVIII-SingleChain, with the Chinese population, the aim of this study in China is to investigate the pharmacokinetics (PK) of rVIII-SingleChain after an initial and repeat dose and to assess efficacy and safety during 2 to 3 times weekly prophylaxis treatment with rVIII-SingleChain in male Chinese PTPs with severe hemophilia A (FVIII activity less than [<] 1%).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • • Male Chinese participants <= 65 years of age.

  • • Participants with severe hemophilia A (FVIII activity < 1%).

  • • Participants who have received FVIII products for >= 150 EDs (>= 6 years of age)or >= 50 EDs (< 6 years of age).

Exclusion

Exclusion Criteria:

  • • Known hypersensitivity (allergic reaction or anaphylaxis) to any FVIII product orhamster protein.

  • • Known congenital or acquired coagulation disorder other than congenital FVIIIdeficiency.

  • • Currently receiving intravenous (IV) immunomodulating agents such asimmunoglobulin or chronic systemic corticosteroid treatment.

  • • Receiving any cryoprecipitate, whole blood, or plasma within 30 days beforeadministration of rVIII-SingleChain.

  • • Use of traditional or herbal Chinese medicine(s) with an impact on hemophilia,including coagulation, within 28 days before Day 1 and / or refusal to abstain fromthese during the study until the end of the participant's participation in thestudy.

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: Recombinant single-chain factor VIII (rVIII-SingleChain)
Phase: 3
Study Start date:
January 09, 2025
Estimated Completion Date:
October 26, 2026

Connect with a study center

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui 230000
    China

    Site Not Available

  • The Second Hospital of Anhui Medical University

    Hefei 1808722, Anhui 1818058 230000
    China

    Site Not Available

  • Beijing Children's Hospital

    Beijing, Beijing Municipality 100045
    China

    Site Not Available

  • Beijing Children's Hospital

    Beijing 1816670, Beijing Municipality 2038349 100045
    China

    Site Not Available

  • Children's Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality 400014
    China

    Site Not Available

  • Children's Hospital of Chongqing Medical University

    Chongqing 1814906, Chongqing Municipality 1814905 400014
    China

    Site Not Available

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian 350001
    China

    Site Not Available

  • Fujian Medical University Union Hospital

    Fuzhou 1810821, Fujian 1811017 350001
    China

    Site Not Available

  • Guangzhou Women and Children's Medical Center

    Guangzhou, Guangdong 510623
    China

    Site Not Available

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong 515399
    China

    Site Not Available

  • Guangzhou Women and Children's Medical Center

    Guangzhou 1809858, Guangdong 1809935 510623
    China

    Active - Recruiting

  • Nanfang Hospital of Southern Medical University

    Guangzhou 1809858, Guangdong 1809935 515399
    China

    Site Not Available

  • Liuzhou People's Hospital

    Liuchow, Guangxi 545006
    China

    Site Not Available

  • Liuzhou People's Hospital

    Liuzhou, Guangxi 545006
    China

    Site Not Available

  • Liuzhou People's Hospital

    Liuchow 1803300, Guangxi 1809867 545006
    China

    Site Not Available

  • Liuzhou People's Hospital

    Liuzhou 1803300, Guangxi 1809867 545006
    China

    Site Not Available

  • North China University of Science and Technology Affiliated Hospital

    Tangshan, Hebei 63000
    China

    Site Not Available

  • Hospital of Hematology, Chinese Academy of Medical Sciences

    Tianjin, Hebei 300020
    China

    Site Not Available

  • North China University of Science and Technology Affiliated Hospital

    Tangshan 1793346, Hebei 1808773 63000
    China

    Site Not Available

  • Henan children's hospital Zhengzhou children's Hospital

    Zhengzhou, Henan 450053
    China

    Site Not Available

  • Henan children's hospital Zhengzhou children's Hospital

    Zhengzhou 1784658, Henan 1808520 450053
    China

    Site Not Available

  • Hunan Provincial Children's Hospital

    Changsha, Hunan 410021
    China

    Site Not Available

  • Hunan Provincial Children's Hospital

    Changsha 1815577, Hunan 1806691 410021
    China

    Site Not Available

  • Nanjing Children's Hospital

    Nanjing, Jiangsu 210008
    China

    Site Not Available

  • XuZhou Children's Hospital

    Xuzhou, Jiangsu 221006
    China

    Site Not Available

  • Nanjing Children's Hospital

    Nanjing 1799962, Jiangsu 1806260 210008
    China

    Site Not Available

  • XuZhou Children's Hospital

    Xuzhou 10630003, Jiangsu 1806260 221006
    China

    Site Not Available

  • Jiangxi Provincial People's Hospital

    Nanchang, Jiangxi 212028
    China

    Site Not Available

  • Jiangxi Provincial People's Hospital

    Nanchang 1800163, Jiangxi 1806222 212028
    China

    Site Not Available

  • Quinghai Provincial People's Hospital

    Xining, Qinghai 81000
    China

    Site Not Available

  • Quinghai Provincial People's Hospital

    Xining 1788852, Qinghai 1280239 81000
    China

    Site Not Available

  • Jinan Central Hospital

    Jinan, Shandong 250013
    China

    Site Not Available

  • Qingdao Women and Children's Hospital

    Qingdao, Shandong 266071
    China

    Site Not Available

  • Jinan Central Hospital

    Jinan 1805753, Shandong 1796328 250013
    China

    Site Not Available

  • Qingdao Women and Children's Hospital

    Qingdao 1797929, Shandong 1796328 266071
    China

    Site Not Available

  • Shanghai Jiaotong University School of Medicine, Ruijin Hospital

    Shanghai, Shanghai Municipality 200020
    China

    Site Not Available

  • Ruijin Hospital, hanghai Jiaotong University School of Medicine

    Shanghai 1796236, Shanghai Municipality 1796231 200020
    China

    Site Not Available

  • Shanghai Jiaotong University School of Medicine, Ruijin Hospital

    Shanghai 1796236, Shanghai Municipality 1796231 200020
    China

    Active - Recruiting

  • The Children's Hospital Zhejiang University School of Medicine

    Shanghai 1796236, Shanghai Municipality 1796231 200020
    China

    Site Not Available

  • The second affiliated hospital of Kunming Medical University

    Kunming, Yunan 650011
    China

    Site Not Available

  • The second affiliated hospital of Kunming Medical University

    Kunming 1804651, Yunan 650011
    China

    Site Not Available

  • The Children's Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310005
    China

    Site Not Available

  • The Children's Hospital Zhejiang University School of Medicine

    Hangzhou 1808926, Zhejiang 1784764 310005
    China

    Site Not Available

  • Henan children's hospital Zhengzhou children's Hospital

    Henan 9641798,
    China

    Site Not Available

  • Nanjing Children's Hospital

    Jiangsu,
    China

    Site Not Available

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