drugset / Trial / NCT03815318
Evaluation of SCT800 in Prophylaxis Therapy on Previous Treated Patients With Severe Hemophilia A
Phase 3
Completed
73 enrolled
Sinocelltech Ltd.
Chinese Academy of Medical Sciences · collabParexel · collabQ2 Solutions · collab
NaSingle-groupOpen-labelPrevention
Summary
This study is a multi-center, open-label, single-arm trial to evaluate the efficacy,safety and pharmacokinetics of SCT800 in regular prophylaxis and perioperative treatment in patients (≥12 years old) with severe hemophilia A who have been previously treated with coagulation factor VIII(FVIII:C) . 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 and prophylaxis with SCT800 shall continue for 24 consecutive weeks.
Timeline
- Start
- 2019-01-21
- Primary completion
- 2020-01-16
- Completion
- 2020-01-16
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SCT800 | Protein / enzyme biologic | 25 iu/kg | Intravenous |
| Subject | SCT800 | Protein / enzyme biologic | 50 iu/kg | Intravenous |