[Translation] A single-arm, open-label, multicenter clinical trial of the efficacy and safety of recombinant human coagulation factor VIII-Fc fusion protein for injection in patients with hemophilia A (adults and adolescents)
主要目的:评价注射用重组人凝血因子VIII-Fc融合蛋白在血友病A受试者中进行按需和预防治疗的有效性。 次要目的:评价注射用重组人凝血因子VIII-Fc融合蛋白用于血友病A受试者的止血效果、预防出血效果、生存质量及安全性。
[Translation] Main objective: To evaluate the efficacy of recombinant human coagulation factor VIII-Fc fusion protein for injection in on-demand and prophylactic treatment in hemophilia A subjects. Secondary objective: To evaluate the hemostatic effect, prevention effect, quality of life and safety of recombinant human coagulation factor VIII-Fc fusion protein for injection in subjects with hemophilia A.