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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

Testing a treatment to prevent bleeding during surgery for hemophilia patients.

Recruiting
12-65 years
Male
Phase 3
  • Simplified description (AI rewritten)
  • Technical description (Original)

This study is testing a medicine called Coagulation Factor VIIa to see if it can help people with a bleeding problem called hemophilia. Hemophilia means their blood doesn’t clot well, leading to excessive bleeding. The study is for those who have inhibitors, which are like blockers that stop other medicines from working. It is for people aged 12-65 having planned surgeries. Participants must not have other bleeding disorders, be on certain medications, or have allergies to rabbits. They will need to meet other health requirements as well.

  • Length: Participation is needed during surgery and recovery.
  • Visits: Regular check-ups during the study period.
  • Risks: Possible side effects include allergic reactions or bleeding issues.
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Study details
    Hemophilia

NCT05695391

Laboratoire français de Fractionnement et de Biotechnologies

12 October 2024

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