Evaluation of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein FRSW107 for Preventing Bleeding in Men 12-65 with Severe Hemophilia A

What this Trial Is About

This research aims to evaluate Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection FRSW107 as a preventive treatment in men aged 12 to 65 with severe Hemophilia A, a condition characterized by a deficiency of Factor VIII. The study focuses on assessing the efficacy, safety, immune response, quality of life, and pharmacokinetic properties of this treatment in patients who have previously received therapy for severe Hemophilia A. Participants will receive FRSW107 either as part of a pharmacokinetic PK subgroup or a non-PK subgroup. Subjects in the PK subgroup will receive single and multiple doses of 50 IUkg at specified visits, with blood samples collected to analyze drug behavior in the body. Based on PK data, individualized prophylactic dosing will be adjusted to maintain Factor VIII activity above 1%, with recommended doses between 25 to 50 IUkg every three days. Those not in the PK subgroup will receive a fixed prophylactic dose within this range. In case of breakthrough bleeding, dosing adjustments will be made as needed. Throughout the 6-month study period, participants will be monitored regularly to record bleeding episodes, joint health status, quality of life, dosing patterns, and pharmacokinetic outcomes. Safety and immune responses will be evaluated, including detailed blood tests and questionnaires. The primary outcome is the annualized bleeding rate, with secondary outcomes covering multiple measures of bleeding control, treatment effectiveness, and patient well-being. The entire study is conducted under medical supervision with ongoing assessments to ensure participant safety and treatment adherence.

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