drugset / Trial / NCT04061109

Safety, Efficacy Evaluation of Recombinant Coagulation Factor VIII Injection in Subjects With Hemophilia A.

NCT04061109

NaSingle-groupOpen-labelPrevention

Summary

This is a multi-center, open-label, single-arm trial to evaluate the efficacy and safety of Recombinant Coagulation Factor VIII in patients with hemophilia A . Recombinant Coagulation Factor VIII is prophylactic administrated 25 - 35 IU/kg once every other day or three times per week which should be continuous for 24 weeks.

Timeline

Start
2019-05-15
Primary completion
2020-03
Completion
2020-03

Drugs

EvaluationDrugModalityDoseRoute
Subject SCT800 Protein / enzyme biologic 25 iu/kg Other
Subject SCT800 Protein / enzyme biologic 35 iu/kg Other

Indications