NCT06738485

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: CSL Behring · Industry
• Sex: Male
• Age: 0 Days – 65 Years
• Healthy volunteers: Not accepted

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%).

Conditions

• Congenital Hemophilia A

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant single-chain factor VIII (rVIII-SingleChain)	Lyophilized powder for solution for intravenous injection

Timeline

• Start date: 2025-01-09
• Primary completion: 2026-06-26
• Completion: 2026-06-26
• First posted: 2024-12-17
• Last updated: 2026-01-08

Locations

20 sites across 1 country: China