Evaluation of SCT800 in Prophylaxis Therapy on Previous Treated Patients With Severe Hemophilia A
Status:
Completed
Trial end date:
2020-01-16
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Sinocelltech Ltd.
Collaborators:
Chinese Academy of Medical Sciences Parexel Q2 Solutions