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

Completed
Phase of Trial: Phase III

Latest Information Update: 23 Jun 2017

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

    • 06 Jan 2017 According to LFB media release, US FDA has accepted for review Biologic License Application (BLA) of Coagulation Factor VIIa Recombinant as a treatment for congenital hemophilia A or B in adolescent and adult congenital hemophilia A or B patients with inhibitors, based on data from PERSEPT program.
    • 04 Sep 2015 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
    • 10 Jun 2015 Planned End Date changed from 1 May 2015 to 1 Aug 2015 as reported by ClinicalTrials.gov record.
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