ALONG: An Open-Label, Multicenter Evaluation of the Safety, Pharmacokinetics, and Efficacy of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in the Prevention and Treatment of Bleeding in Previously Treated Subjects With Severe Hemophilia A

Trial Profile

ALONG: An Open-Label, Multicenter Evaluation of the Safety, Pharmacokinetics, and Efficacy of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in the Prevention and Treatment of Bleeding in Previously Treated Subjects With Severe Hemophilia A

Completed
Phase of Trial: Phase III

Latest Information Update: 20 Aug 2017

At a glance

  • Drugs Efmoroctocog alfa (Primary) ; Rurioctocog alfa
  • Indications Haemophilia A
  • Focus Adverse reactions; Pharmacokinetics; Registrational; Therapeutic Use
  • Acronyms A-LONG; ALONG
  • Sponsors Biogen Idec
  • Most Recent Events

    • 18 May 2017 Based on the data from this and the Kids A-LONG trial, the Saudi Food & Drug Authority (SFDA) in the Kingdom of Saudi Arabia approved Elocta (efmoroctocog alfa), a recombinant human factor VIII Fc-fusion protein with an extended half-life, for the treatment of haemophilia A according to a Swedish Orphan Biovitrum media release.
    • 06 Dec 2016 Interim analysis (data cut 8 Dec 2014) for long-term safety and efficacy of rFVIIFc in Adults/Adolescents was presented at the 58th Annual Meeting and Exposition of the American Society of Hematology
    • 21 Nov 2016 According to a Swedish Orphan Biovitrum AB media release, based on the data from this and Kids A-LONG trial, Swedish Orphan Biovitrum AB (publ) (STO:SOBI) (Sobi) today announces that the Ministry of Health in Kuwait has approved Elocta (efmoroctocog alfa), a recombinant human factor VIII Fc-fusion protein with an extended half-life, for the treatment of haemophilia A.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top