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An Open-Label, Multicenter Evaluation of Safety, Pharmacokinetics, and Efficacy of Recombinant Coagulation Factor VIII Fc Fusion Protein, BIIB031, in the Prevention and Treatment of Bleeding Episodes in Pediatric Subjects With Hemophilia A

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Trial Profile

An Open-Label, Multicenter Evaluation of Safety, Pharmacokinetics, and Efficacy of Recombinant Coagulation Factor VIII Fc Fusion Protein, BIIB031, in the Prevention and Treatment of Bleeding Episodes in Pediatric Subjects With Hemophilia A

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 25 Jul 2022

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At a glance

  • Drugs Efmoroctocog alfa (Primary) ; Factor VIII stimulants
  • Indications Haemophilia A
  • Focus Registrational; Therapeutic Use
  • Acronyms Kids A-LONG; Kids ALONG
  • Sponsors Biogen; Bioverativ

    • Most Recent Events

    • 14 Mar 2021 Results of population pharmacokinetic model from NCT01027377, NCT01181128 and NCT01458106 published in the Journal of Clinical Pharmacology
    • 10 May 2019 According to a Swedish Orphan Biovitrum media release, final pooled post-hoc analysis data from A-LONG, Kids A-LONG and ASPIRE studies will be presented at the World Federation of Hemophilia's 16th International Musculoskeletal Congress (MSK).
    • 24 Apr 2019 According to a Swedish Orphan Biovitrum media release, long term safety and efficay data was presented at the European Association of Haemophilia and Allied Disorders (EAHAD) conference.

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