An Open-label Single-arm Multicentre Non-controlled Phase 3 a Trial Investigating Safety and Efficacy of Nonacog Beta Pegol (N9-GP) in Prophylaxis and Treatment of Bleeding Episodes in Previously Untreated Patients With Haemophilia B (FIX Activity Below or Equal to 2 Percent)

Trial Profile

An Open-label Single-arm Multicentre Non-controlled Phase 3 a Trial Investigating Safety and Efficacy of Nonacog Beta Pegol (N9-GP) in Prophylaxis and Treatment of Bleeding Episodes in Previously Untreated Patients With Haemophilia B (FIX Activity Below or Equal to 2 Percent)

Recruiting
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 Therapeutic Use
  • Acronyms Paradigm 6
  • Sponsors Novo Nordisk
  • Most Recent Events

    • 10 Jun 2017 Biomarkers information updated
    • 21 Feb 2017 Planned End Date changed from 1 Oct 2022 to 30 Oct 2022.
    • 21 Feb 2017 Planned primary completion date changed from 1 Oct 2022 to 30 Oct 2022.
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