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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

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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 04 Aug 2023

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At a glance

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.
  • 08 Sep 2021 Planned number of patients changed from 99 to 115.
  • 29 Jun 2021 Status changed from active, no longer recruiting to completed.

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