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SAFE Study: Safety of aPCC Following Emicizumab Prophylaxis

NCT04563520 ↗

Phase 3 Recruiting 5 enrolled Emory University Takeda Pharmaceuticals North America, Inc. · collab
NaSingle-groupOpen-labelTreatment

Summary

The purpose of the aPCC-emicizumab safety study is to investigate the hemostatic efficacy as measured by thrombin generation, of a low personalized dose of aPCC (FEIBA) in children and adults with hemophilia A and inhibitors on emicizumab prophylaxis.

Timeline

Start
2026-06
Primary completion
2027-03
Completion
2027-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Factor VIII Inhibitor Bypassing Activity Unknown 15 iu/kg Intravenous
Subject Factor VIII Inhibitor Bypassing Activity Unknown 25 iu/kg Intravenous
Background Emicizumab Monoclonal antibody — —
Background eptacog alfa (activated) Protein / enzyme biologic — —

Indications

hemophilia A