An Open-label, Multicenter Evaluation of Safety, Pharmacokinetics and Efficacy of Recombinant Coagulation Factor IX Fc Fusion Protein, BIIB029, in the Prevention and Treatment of Bleeding Episodes in Pediatric Subjects With Hemophilia B

Trial Profile

An Open-label, Multicenter Evaluation of Safety, Pharmacokinetics and Efficacy of Recombinant Coagulation Factor IX Fc Fusion Protein, BIIB029, in the Prevention and Treatment of Bleeding Episodes in Pediatric Subjects With Hemophilia B

Completed
Phase of Trial: Phase III

Latest Information Update: 25 Oct 2017

At a glance

  • Drugs Eftrenonacog alfa (Primary) ; Factor X stimulants
  • Indications Haemophilia B
  • Focus Registrational; Therapeutic Use
  • Acronyms Kids B-LONG; Kids BLONG
  • Sponsors Biogen
  • Most Recent Events

    • 25 Oct 2017 According to a Swedish Orphan Biovitrum AB media release, the Saudi Food & Drug Authority (SFDA) in the Kingdom of Saudi Arabia has approved Alprolix (eftrenonacog alfa), for the treatment of haemophilia B. The SFDA approval was based on B-LONG and Kids B-LONG studies.
    • 10 Jun 2017 Biomarkers information updated
    • 02 Feb 2017 Results were published in The Lancet Haematology, according to a Swedish Orphan Biovitrum media release.
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