drugset / Trial / NCT03815318

Evaluation of SCT800 in Prophylaxis Therapy on Previous Treated Patients With Severe Hemophilia A

NCT03815318

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

EvaluationDrugModalityDoseRoute
Subject SCT800 Protein / enzyme biologic 25 iu/kg Intravenous
Subject SCT800 Protein / enzyme biologic 50 iu/kg Intravenous

Indications