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
Latest Information Update: 04 Aug 2023
At a glance
- Drugs Albutrepenonacog alfa (Primary) ; Albutrepenonacog alfa (Primary)
- Indications Haemophilia B
- Focus Adverse reactions; Registrational; Therapeutic Use
- Acronyms PROLONG-9FP
- Sponsors CSL Behring
- 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.