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An Open-label Single-arm Multicentre Non-controlled Phase 3a Trial Investigating Safety and Efficacy of N8-GP in Prophylaxis and Treatment of Bleeding Episodes in Previously Untreated Paediatric Patients With Severe Haemophilia A

Trial Profile

An Open-label Single-arm Multicentre Non-controlled Phase 3a Trial Investigating Safety and Efficacy of N8-GP in Prophylaxis and Treatment of Bleeding Episodes in Previously Untreated Paediatric Patients With Severe Haemophilia A

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 23 Aug 2019

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At a glance

  • Drugs Turoctocog alfa pegol (Primary)
  • Indications Haemophilia A
  • Focus Pharmacodynamics; Registrational
  • Acronyms pathfinder6
  • Sponsors Novo Nordisk
  • Most Recent Events

    • 20 Jun 2019 According to a Novo Nordisk media release, the European Commission has granted marketing authorisation for Esperoct for the treatment of adolescents (=12 years of age) and adults with haemophilia A.
    • 26 Apr 2019 The Committee for Medicinal Products for Human Use (CHMP), under the European Medicines Agency (EMA), adopted a positive opinion for the use of Esperoct (turoctocog alfa pegol, N8-GP) recommending marketing authorisation for the treatment of adolescents and adults with haemophilia A, based on the results from this study.
    • 19 Feb 2019 According to a Novo Nordisk media release, the US Food and Drug Administration (FDA) has approved the Biologics License Application for ESPEROCT for the treatment of adults and children with haemophilia A. The approval is based on five prospective, multi-centre clinical trials in previously treated people with severe haemophilia A (<1% endogenous FVIII activity) and no history of inhibitors.
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