drugset / Trial / NCT03947567
Safety and Efficacy of Long-term Treatment With SCT800 in Previously Treated Hemophilia A Patients.
NaSingle-groupOpen-labelPrevention
Summary
This study is a multi-center, open-label, extension trial to evaluate the safety, efficacy of SCT800 in long term prophylaxis and on-demand treatment in patients with severe hemophilia A who have been previously treated with coagulation factor VIII(FVIII) . This study includes two phases: the screening period and prophylaxis period.Prophylaxis with 25 - 50 IU/kg of SCT800 shall be administered once every other day or three times per week starting from V1, on-demand treatment is given when bleeding episodes occur. The study period is 120 consecutive weeks.
Timeline
- Start
- 2019-07-26
- Primary completion
- 2025-04-01
- Completion
- 2025-04-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SCT800 | Protein / enzyme biologic | 25 iu/kg | — |
| Subject | SCT800 | Protein / enzyme biologic | 50 iu/kg | — |