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A Phase III Open-label, Multicenter, Pharmacokinetic, Safety and Efficacy Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Previously Treated Children With Hemophilia B

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Trial Profile

A Phase III Open-label, Multicenter, Pharmacokinetic, Safety and Efficacy Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Previously Treated Children With Hemophilia B

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 04 Aug 2023

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At a glance

  • Drugs Albutrepenonacog alfa (Primary)
  • Indications Haemophilia B
  • Focus Adverse reactions; Pharmacokinetics; 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.
  • 12 Dec 2017 Long-term efficacy and safety results from an ongoing phase 3b extension clinical trial presented at the 59th Annual Meeting and Exposition of the American Society of Hematology
  • 03 Dec 2016 According to a CSL Behring media release, the results from a pooled analysis of this and other study (700240865 ) of global PROLONG-9FP program were presented at the 58th annual meeting of the American Society of Hematology (ASH).

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