Clinical Trial

Phase 3 Clinical Project of Pegylated Recombinant Human Coagulation Factor VIII-Fc Fusion Protein

Recruiting Phase 3
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Record status
This record was last updated February 28, 2024 (before its estimated January 15, 2026 completion). Its status may not reflect the trial's current state.
Summary
To evaluate the prophylactic efficacy of recombinant human coagulation factor Ⅷ-Fc fusion protein (FRSW117) for injection in patients with severe hemophilia A. To evaluate the safety of recombinant human coagulation factor Ⅷ-Fc fusion protein (FRSW117) for injection in patients with severe hemophilia A. Secondary purpose: To evaluate the efficacy of recombinant human coagulation factor Ⅷ-Fc fusion protein for injection (FRSW117) in hemostasis and surgical hemostasis in patients with severe hemophilia A. To evaluate the pharmacokinetic (PK) characteristics of recombinant human coagulation factor Ⅷ-Fc fusion protein (FRSW117) for injection in treated patients with severe hemophilia A. To evaluate the immunogenicity of recombinant human coagulation factor Ⅷ-Fc fusion protein (FRSW117) for injection in treated patients with severe hemophilia A.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-11-16; most recent amendment 2024-02-27.
Status change: Not Yet Recruiting → Recruiting 2024-02-27
Trial Details
NCT Number NCT06142552
Lead Sponsor Hangzhou Gensciences Biopharmaceutical Co., Ltd.
Conditions Severe Hemophilia A
Enrollment 120 participants
Start Date 2023-12-27
Primary Completion 2026-01-15 (estimated)
Study Completion 2026-09-01 (estimated)
Updated on ClinicalTrials.gov 2024-02-28