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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

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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

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 04 Aug 2023

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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

  • 01 Aug 2023 Results assessing the impact of prophylaxis with rIX-FP, a fusion protein linking recombinant factor IX (FIX) with human albumin, on joint outcomes in PROLONG-9FP phase 3 pivotal studies (NCT01496274; NCT01662531) and the phase 3b extension study (NCT02053792), published in the European Journal of Haematology.
  • 01 Feb 2021 According to a Sobi media release, results of an analysis using matching-adjusted indirect comparison of B-LONG and PROLONG-9FP trials will be presented at the 14th European Association of Haemophilia and Allied Disorders (EAHAD) virtual conference from 3rd to 5th Feb 2021.
  • 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.

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