Congenital Hemophilia A

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

NCT06738485 | PHASE 3 | INTERVENTIONAL

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%).

10 Sites

60 Participants

RECRUITING

to 65 Years

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SUBMIT

The Second Hospital of Anhui Medical University

Hefei,Anhui,China,230000

Beijing Children's Hospital

Beijing,Beijing,China,100045

Fujian Medical University Union Hospital

Fuzhou,Fujian,China,350001

Guangzhou Women and Children's Medical Center

Guangzhou,Guangdong,China,510623

Nanfang Hospital of Southern Medical University

Guangzhou,Guangdong,China,510623

Hospital of Hematology, Chinese Academy of Medical Sciences

Tianjin,Hebei,China,300020

Hunan Provincial Children's Hospital

Changsha,Hunan,China,410021

XuZhou Children's Hospital

Xuzhou,Jiangsu,China,221006

Quinghai Provincial People's Hospital

Xining,Qinghai,China,81000

Qingdao Women and Children's Hospital

Qingdao,Shandong,China,266071

Study Eligibility Criteria

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 Criteria

* Known hypersensitivity (allergic reaction or anaphylaxis) to any FVIII product or hamster protein.
* Known congenital or acquired coagulation disorder other than congenital FVIII deficiency.
* 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.

Additional Studies

Additional studies can be found at ClinicalTrials.gov