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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 06 Nov 2021

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At a glance

  • Drugs Albutrepenonacog alfa (Primary)
  • Indications Haemophilia B
  • Focus Adverse reactions
  • 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.
  • 26 Jul 2016 According to CSL Behring media release, Elena Santagostino, M.D., Ph.D., Professor in the Medical School of Clinical and Experimental Hematology at the University of Milan/IRCCS Maggiore Hospital is the lead investigator of this study.

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