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A Phase III Study on the Safety, Pharmacokinetics and Efficacy of Coagulation Factor VIIa (Recombinant) in Congenital Hemophilia A or B Patients With Inhibitors to Factor VIII or IX

Trial Profile

A Phase III Study on the Safety, Pharmacokinetics and Efficacy of Coagulation Factor VIIa (Recombinant) in Congenital Hemophilia A or B Patients With Inhibitors to Factor VIII or IX

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 18 Jan 2023

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At a glance

  • Drugs Recombinant factor VIIa (Primary)
  • Indications Haemophilia A; Haemophilia B
  • Focus Registrational; Therapeutic Use
  • Acronyms PERSEPT 1
  • Sponsors rEVO Biologics
  • Most Recent Events

    • 13 Dec 2022 Results presented at the 64th American Society of Hematology Annual Meeting and Exposition
    • 13 Dec 2022 Results assessing the efficacy of Recombinant-factor-VIIa presented at the 64th American Society of Hematology Annual Meeting and Exposition.
    • 15 Jul 2022 According to LFB media release, the European Medicines Agency (EMA) has granted a Marketing Authorisation for CEVENFACTA (eptacog beta) for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures, based on data from PERSEPT 1 and PERSEPT 3 studies.
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