Phase 3 Clinical Project of Pegylated Recombinant Human Coagulation Factor VIII-Fc Fusion Protein
Status:
Recruiting
Trial end date:
2026-09-01
Target enrollment:
Participant gender:
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.