Overview

An Open Label Study to Determine the Safety and Efficacy of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection in Adolescent and Adult Patients With Hemophilia A.

Status:
Active, not recruiting

Trial end date:
2022-07-30

Target enrollment:

Participant gender:

Summary

The primary objectives of the study are to evaluate the efficacy of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection (FRSW107) in the Prevention and Treatment of Bleeding in patients with hemophilia A. The secondary objectives are to evaluate the efficacy and safety of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection (FRSW107) in the prevention and treatment of bleeding episodes, to investigate the quality of life in patients who used the FRSW107.

Phase:

Phase 3

Details

Lead Sponsor:

Zhengzhou Gensciences Inc

Collaborator:

Haimen Gensciences lnc

Treatments:

Factor VIII
Immunoglobulin Fc Fragments