A Phase 3b Open-label, Multicenter, Safety and Efficacy Extension Study of a Recombinant Coagulation Factor IX Albumin Fusion Protein (rIX-FP) in Subjects with Hemophilia B

Trial Profile

A Phase 3b Open-label, Multicenter, Safety and Efficacy Extension Study of a Recombinant Coagulation Factor IX Albumin Fusion Protein (rIX-FP) in Subjects with Hemophilia B

Recruiting
Phase of Trial: Phase III

Latest Information Update: 20 Nov 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

    • 05 Sep 2017 Planned End Date changed from 1 Jan 2022 to 30 Apr 2020.
    • 10 Jun 2017 Biomarkers information updated
    • 03 Dec 2016 According to a CSL Behring media release, the results from a pooled analysis of this and other study (700245910) of global PROLONG-9FP program were presented at the 58th annual meeting of the American Society of Hematology (ASH).
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