drugset / Trial / NCT04845399
Phase III Expansion Trial for Determining the Safety and Efficacy of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection in Adolescent and Adult Patients With Hemophilia A
Phase 3
Completed
101 enrolled
Zhengzhou Gensciences Inc
Hangzhou Gensciences Biopharmaceutical Co., Ltd. · collab
NaSingle-groupOpen-labelTreatment
Summary
The primary objectives of the study are to further evaluate the efficacy and safety of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection (FRSW107) in adolescent and adult patients with hemophilia A.
Timeline
- Start
- 2021-04-16
- Primary completion
- 2021-06-26
- Completion
- 2021-06-26
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Recombinant Human Coagulation Factor VIII-Fc Fusion Protein | Protein / enzyme biologic | 50 iu/kg | — |