NCT06738485CompletedPhase 3
Recombinant Single-chain Factor VIII (rVIII-SingleChain) in Chinese Participants With Hemophilia A Previously Treated With FVIII Products
A Phase 3, Open-label, Multicenter, Pharmacokinetics, Efficacy, and Safety Study of a Recombinant Single-chain Factor VIII (rVIII-SingleChain) in Chinese Previously Treated Patients (PTPs) With Hemophilia A
Source: ClinicalTrials.gov · Last updated 23 Oct 2026
Brief summary (registry, in English)
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%).
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 62 (actual)
- First submitted
- 12 Dec 2024
- Start date
- 9 Jan 2025
- Primary completion date
- 23 Sept 2026
- Lead sponsor
- CSL Behring
- Diseases
- Haemophilia
- NCT number
- NCT06738485
- EudraCT number
- 2023-001026-34
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 62
- From 9 Jan 2025 to the primary completion date, 23 Sept 2026
- 20 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- • Currently receiving intravenous (IV) immunomodulating agents such as immunoglobulin or chronic systemic corticosteroid treatment.
- • Receiving any cryoprecipitate, whole blood, or plasma within 30 days before administration 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 from these during the study until the end of the participant's participation in the study.
Other illness
- • Known hypersensitivity (allergic reaction or anaphylaxis) to any FVIII product or hamster protein.
- • Known congenital or acquired coagulation disorder other than congenital FVIII deficiency.
Who the study is looking for
- • 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).
Age in the registry: 0 days to 65 years · Sex: Male · Does not accept healthy volunteers
Sites (20)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Children's Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Hunan Provincial Children's Hospital Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Children's Hospital of Chongqing Medical University Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Fujian Medical University Union Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Guangzhou Women and Children's medical center Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Nanfang Hospital of Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The Children's Hospital, Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| The Second Hospital of Anhui Medical University Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
| Jinan Central Hospital Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| The Second Affiliated Hospital of Kunming Medical University Coordinator of this site? Confirm its status | Kunming | China | Unknown status |
| Liuzhou People's Hospital Coordinator of this site? Confirm its status | Liuzhou | China | Unknown status |
| Jiangxi Provincial People's Hospital Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| Nanjing Children's Hospital Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Qingdao Women and Children's Hospital Coordinator of this site? Confirm its status | Qingdao | China | Unknown status |
| Shanghai Jiaotong University School of Medicine Ruijin Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| North China University of Science and Technology Affiliated Hospital Coordinator of this site? Confirm its status | Tangshan | China | Unknown status |
| Hospital of Hematology, Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Quinghai Provincial People's Hospital Coordinator of this site? Confirm its status | Xining | China | Unknown status |
| Xuzhou Children's Hospital Coordinator of this site? Confirm its status | Xuzhou | China | Unknown status |
| Henan Children's Hospital(Zhengzhou Children's Hospital) Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.