An Open-Label, Multicenter Evaluation of the Safety and Efficacy of Recombinant Coagulation Factor IX Fc Fusion Protein (rFIXFc; BIIB029) in the Prevention and Treatment of Bleeding in Previously Untreated Patients With Severe Hemophilia B

Trial Profile

An Open-Label, Multicenter Evaluation of the Safety and Efficacy of Recombinant Coagulation Factor IX Fc Fusion Protein (rFIXFc; BIIB029) in the Prevention and Treatment of Bleeding in Previously Untreated Patients With Severe Hemophilia B

Recruiting
Phase of Trial: Phase III

Latest Information Update: 17 Aug 2017

At a glance

  • Drugs Eftrenonacog alfa (Primary)
  • Indications Haemophilia B
  • Focus Registrational; Therapeutic Use
  • Acronyms PUPs B-LONG
  • Sponsors Biogen; Bioverativ
  • Most Recent Events

    • 21 Dec 2016 Planned End Date changed from 1 Jun 2019 to 1 May 2022.
    • 28 Oct 2016 According to a Swedish Orphan Biovitrum, Swiss Agency for Therapeutic Products, Swissmedic, has approved Alprolix (eftrenonacog alfa) for the treatment of haemophilia B.
    • 18 Jun 2014 New trial record
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