Trials / Completed
CompletedNCT04845399
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
A Single-Arm, Multicenter, Open-label Phase III Expansion Trial Evaluating 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
- 101 (actual)
- Sponsor
- Zhengzhou Gensciences Inc · Industry
- Sex
- Male
- Age
- 12 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection | Participants received prophylaxis treatment at 50 IU/ kg every three days.30-50 IU/kg is recommended to administration while bleeding occurs during the experiment. |
Timeline
- Start date
- 2021-04-16
- Primary completion
- 2021-06-26
- Completion
- 2021-06-26
- First posted
- 2021-04-15
- Last updated
- 2023-08-29
Locations
16 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04845399. Inclusion in this directory is not an endorsement.