A Phase II/III Open-label, Multicenter, Safety and Efficacy Study of a Recombinant Coagulation Factor IX Albumin Fusion Protein (rIX-FP) in Subjects With Hemophilia B

Trial Profile

A Phase II/III Open-label, Multicenter, Safety and Efficacy Study of a Recombinant Coagulation Factor IX Albumin Fusion Protein (rIX-FP) in Subjects With Hemophilia B

Completed
Phase of Trial: Phase II/III

Latest Information Update: 26 Aug 2017

At a glance

  • Drugs Albutrepenonacog alfa (Primary)
  • Indications Haemophilia B
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms PROLONG-9FP
  • Sponsors CSL Behring
  • Most Recent Events

    • 10 Jun 2017 Biomarkers information updated
    • 03 Oct 2016 According to a CSL Behring media release, IDELVION subsequently approved in Australia (Oct 2016) based on results from the PROLONG-9FP clinical development program.
    • 29 Sep 2016 According to a CSL Behring media release, Japan's Ministry of Health, Labour and Welfare (MHLW) has approved IDELVION for the prevention of bleeding tendency in patients with factor IX deficiency,based on results from the PROLONG-9FP clinical development program. IDELVION subsequently approved in Australia (Oct 2016), European Union, Switzerland and Canada.
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