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

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%).

NCT Number	NCT06738485
Lead Sponsor	CSL Behring
Conditions	Congenital Hemophilia A
Enrollment	60 participants
Start Date	2025-01-09
Primary Completion	2026-10-26 (estimated)
Study Completion	2026-10-26 (estimated)
Updated on ClinicalTrials.gov	2026-04-23