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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 Pediatric Patients From Birth to <12 Years Old With Inhibitors to Factor VIII or IX: PerSept 2

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Trial Profile

A Phase III Study on the Safety, Pharmacokinetics, and Efficacy of Coagulation Factor VIIa (Recombinant) in Congenital Hemophilia A or B Pediatric Patients From Birth to <12 Years Old With Inhibitors to Factor VIII or IX: PerSept 2

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 28 Feb 2022

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At a glance

  • Drugs Recombinant factor VIIa (Primary)
  • Indications Haemophilia A; Haemophilia B
  • Focus Registrational; Therapeutic Use
  • Acronyms PERSEPT2
  • Sponsors LFB Biotechnologies; rEVO Biologics

    • Most Recent Events

    • 14 Dec 2021 Results of subgroups analysis from (PERSEPT 1 and PERSEPT 2) assessing subset analysis suggests improved caregiver capacity to assess bleeding episode treatment success in three age subgroups, presented at the 63rd American Society of Hematology Annual Meeting and Exposition.
    • 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 Mar 2021 According to LFB media release, sBLA efficacy supplement is currently under FDA review, with a regulatory outcome expected by mid-2021

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