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
Price :
$35
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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
- 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).