NCT05695391

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Laboratoire français de Fractionnement et de Biotechnologies · Industry
• Sex: Male
• Age: 12 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hemophilia

Interventions

Type	Name	Description
BIOLOGICAL	Coagulation Factor VIIa (Recombinant)	LR769

Timeline

• Start date: 2024-06-07
• Primary completion: 2025-06-01
• Completion: 2025-06-01
• First posted: 2023-01-25
• Last updated: 2025-07-09

Locations

15 sites across 6 countries: United States, Malaysia, Mexico, South Africa, Thailand, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study