A PHASE 3, PROSPECTIVE, OPEN-LABEL, RANDOMIZED STUDY TO EVALUATE SAFETY AND EFFICACY OF RECOMBINANT ACTIVATED FVII BI (rFVIIa BI) IN THE TREATMENT OF ACUTE BLEEDING EPISODES PER AN ON-DEMAND REGIMEN IN PATIENTS WITH HEMOPHILIA A OR B WITH INHIBITORS

Trial Profile

A PHASE 3, PROSPECTIVE, OPEN-LABEL, RANDOMIZED STUDY TO EVALUATE SAFETY AND EFFICACY OF RECOMBINANT ACTIVATED FVII BI (rFVIIa BI) IN THE TREATMENT OF ACUTE BLEEDING EPISODES PER AN ON-DEMAND REGIMEN IN PATIENTS WITH HEMOPHILIA A OR B WITH INHIBITORS

Completed
Phase of Trial: Phase III

Latest Information Update: 27 Oct 2016

At a glance

  • Drugs Recombinant factor VIIa (Primary)
  • Indications Haemophilia A; Haemophilia B
  • Focus Registrational; Therapeutic Use
  • Sponsors Baxter Healthcare Corporation
  • Most Recent Events

    • 13 Mar 2015 Primary endpoint (Bleeding episode treatment success) has been met, according to Baxter International media release.
    • 13 Mar 2015 Results published in the Media Release.
    • 11 Dec 2014 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
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