A Multi-centre, Single-blind Trial Evaluating Safety and Efficacy, Including Pharmacokinetics, of NNC-0156-0000-0009 When Used for Treatment and Prophylaxis of Bleeding Episodes in Patients With Haemophilia B

Trial Profile

A Multi-centre, Single-blind Trial Evaluating Safety and Efficacy, Including Pharmacokinetics, of NNC-0156-0000-0009 When Used for Treatment and Prophylaxis of Bleeding Episodes in Patients With Haemophilia B

Completed
Phase of Trial: Phase III

Latest Information Update: 30 Sep 2017

At a glance

  • Drugs Nonacog beta pegol (Primary)
  • Indications Blood coagulation disorders; Haemophilia B
  • Focus Registrational; Therapeutic Use
  • Acronyms paradigm 2
  • Sponsors Novo Nordisk
  • Most Recent Events

    • 10 Jun 2017 Biomarkers information updated
    • 06 Jun 2017 According to a media release, the company expects to launch Refixia in the first Europe
    • 06 Jun 2017 According to a Novo Nordisk media release, based on the results from the paradigm clinical trial programme (see profiles 243891, 243935, 243947,243961 and 244049) and the positive opinion provided on 24 March 2017 by the Committee for Medicinal Products for Human Use (CHMP), the European Commission has granted marketing authorisation for Refixia for the treatment of adolescents and adults with haemophilia B.
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