A Phase 3 Study of the Safety and Efficacy of Coagulation Factor VIIa (Recombinant) for the Prevention of Excessive Bleeding in Patients With Congenital Hemophilia A or B With Inhibitors to Factor VIII or IX Undergoing Elective Major Surgical Procedures SCOPE HIM

Phase 3 Terminated 2 enrolled LFB

NaSingle-groupOpen-labelTreatment

Summary

This is an interventional, prospective, international, multicenter, single-arm, Phase 3, and sequential efficacy and safety study in adolescents and adults with congenital hemophilia A or B with inhibitors to factor VIII (FVIII) or factor IX (FIX) undergoing elective major surgical procedures.

Timeline

Start: 2024-06-07
Primary completion: 2025-06-01
Completion: 2025-06-01

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	eptacog alfa (activated)	Protein / enzyme biologic	—	—

A Phase 3 Study of the Safety and Efficacy of Coagulation Factor VIIa (Recombinant) for the Prevention of Excessive Bleeding in Patients With Congenital Hemophilia A or B With Inhibitors to Factor VIII or IX Undergoing Elective Major Surgical Procedures SCOPE HIM

Summary

Timeline

Drugs

Indications