Clinical Trial

Study of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein (FRSW107) as Prophylactic Treatment.

Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
The indication for this product is to control and prophylaxis in patients with Hemophilia A (congenital Factor VIII deficiency): The Primary Objective: To evaluate the efficacy of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection (FRSW107) for prophylactic treatment in previously treated patients with severe Hemophilia A. Secondary Objectives: To evaluate the health-related quality of life, pharmacokinetic (PK) profiles, safety and immunogenicity of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection (FRSW107) for prophylactic treatment in previously treated subjects with severe Hemophilia A.
Trial Details
NCT Number NCT07684898
Lead Sponsor Hangzhou Gensciences Biopharmaceutical Co., Ltd.
Conditions Severe Hemophilia A
Enrollment 60 participants
Start Date 2026-06-12
Primary Completion 2027-03-09 (estimated)
Study Completion 2027-06-21 (estimated)
Updated on ClinicalTrials.gov 2026-07-06