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Phase 3 Study of Safety and Efficacy of Coagulation Factor VIIa (Recombinant) for Prevention of Excessive Bleeding in Congenital Hemophilia A/B Patients With Inhibitors to Factor VIII/IX Undergoing Elective Surgery/Other Invasive Procedures

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Trial Profile

Phase 3 Study of Safety and Efficacy of Coagulation Factor VIIa (Recombinant) for Prevention of Excessive Bleeding in Congenital Hemophilia A/B Patients With Inhibitors to Factor VIII/IX Undergoing Elective Surgery/Other Invasive Procedures

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 27 Jul 2022

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At a glance

Most Recent Events

  • 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.
  • 01 Nov 2021 Results from three Phase 3 trials (PERSEPT 1, PERSEPT 2 and PERSEPT 3) assessing the EB safety, immunogenicity and thrombotic potential in children and adults who received EB for treatment of bleeding and perioperative care, published in the Haemophilia.
  • 01 Nov 2021 Results published in the Haemophilia

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