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An Open-label, Multicenter, Dose-Escalation Safety and Pharmacokinetic Study of a Recombinant Coagulation Factor IX Albumin Fusion Protein (rIX-FP) in Subjects With Hemophilia B

Trial Profile

An Open-label, Multicenter, Dose-Escalation Safety and Pharmacokinetic Study of a Recombinant Coagulation Factor IX Albumin Fusion Protein (rIX-FP) in Subjects With Hemophilia B

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 30 Sep 2017

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At a glance

  • Drugs Albutrepenonacog alfa (Primary)
  • Indications Haemophilia B
  • Focus Adverse reactions; First in man; Pharmacokinetics
  • Acronyms PROLONG-9FP
  • Sponsors CSL Behring
  • Most Recent Events

    • 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.
    • 11 May 2016 According to a CSL Behring media release, based on results from the PROLONG-9FP clinical development program (from phase I through phase III) the company has been granted seven years of marketing exclusivity by the U.S. Food and Drug Administration (FDA) for IDELVION [Coagulation Factor IX (Recombinant), Albumin Fusion Protein].
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