Trials / Completed
CompletedNCT04456387
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.
An Open-Label, Multicenter Evaluation of the Safety and Efficacy of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection (FRSW107) in Adolescent and Adult Patients With Hemophilia A.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 119 (actual)
- Sponsor
- Zhengzhou Gensciences Inc · Industry
- Sex
- Male
- Age
- 12 Years – 60 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection | Participants received on-demand treatment, doses range from 30 IU/kg to 50 IU/kg, or doses divided on the discretion of the Investigator. |
| DRUG | Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection | Participants received prophylaxis treatment at 50 IU/kg every three days. |
Timeline
- Start date
- 2020-10-15
- Primary completion
- 2021-09-30
- Completion
- 2021-09-30
- First posted
- 2020-07-02
- Last updated
- 2023-12-13
Locations
17 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04456387. Inclusion in this directory is not an endorsement.