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drugset / Trial / NCT05265286

A Study of Repeat Dosing of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection

NCT05265286 ↗

Phase 2 Completed 15 enrolled Hangzhou Gensciences Biopharmaceutical Co., Ltd.
NaSingle-groupOpen-labelTreatment

Summary

Primary objective: To assess the pharmacokinetics, Safety and immunogenicity of Repeat Dosing of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection With Severe Hemophilia A(FRSW117) Secondary objectives: To assess Preliminary efficacy of Repeat Dosing of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection With Severe Hemophilia A.

Timeline

Start
2022-04-14
Primary completion
2022-08-21
Completion
2022-08-21

Drugs

EvaluationDrugModalityDoseRoute
Subject FRSW117 Protein / enzyme biologic 40 iu/kg —
Subject FRSW117 Protein / enzyme biologic 50 iu/kg —

Indications

severe hemophilia A