A Multi-national Trial Evaluating Safety and Efficacy, Including Pharmacokinetics, of NNC 0129-0000-1003 When Administered for Treatment and Prophylaxis of Bleeding in Patients With Haemophilia A

Trial Profile

A Multi-national Trial Evaluating Safety and Efficacy, Including Pharmacokinetics, of NNC 0129-0000-1003 When Administered for Treatment and Prophylaxis of Bleeding in Patients With Haemophilia A

Completed
Phase of Trial: Phase III

Latest Information Update: 27 Feb 2018

At a glance

  • Drugs Turoctocog alfa pegol (Primary)
  • Indications Haemophilia A
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms PATHFINDER 2
  • Sponsors Novo Nordisk
  • Most Recent Events

    • 27 Feb 2018 According to a Novo Nordisk media release, the Company has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for N8-GP. The submission was based on results from the pathfinder clinical trial programme.
    • 01 Dec 2016 Primary endpoint (the incidence rate of FVIII-inhibitors greater than or equal to 0.6 BU (Bethesda Unit)) has been met, according to results of pivotal analysis published in the Thrombosis and Haemostasis journal.
    • 01 Dec 2016 Primary endpoint (annualised bleeding rate in the prophylaxis arm) has been met, according to results of pivotal analysis published in the Thrombosis and Haemostasis journal.
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