scholarly journals Validation of the manufacturing process used to produce long‐acting recombinant factor IX Fc fusion protein

Haemophilia ◽  
2014 ◽  
Vol 20 (4) ◽  
Author(s):  
J. McCue ◽  
D. Osborne ◽  
J. Dumont ◽  
R. Peters ◽  
B. Mei ◽  
...  
Keyword(s):  
Fusion Protein ◽  
Manufacturing Process ◽  
Factor Ix ◽  
Fc Fusion Protein ◽  
Recombinant Factor Ix ◽  
Long Acting

scholarly journals Japanese subject subpopulation analysis of B-LONG: a Phase 3 study of long-acting recombinant factor IX Fc fusion protein

2015 ◽  
Vol 26 (4) ◽  
pp. 420-429 ◽  
Author(s):  
Midori SHIMA ◽  
Katsuyuki FUKUTAKE ◽  
Hideji HANABUSA ◽  
Tadashi MATSUSHITA ◽  
Masashi TAKI ◽  
...  
Keyword(s):  
Fusion Protein ◽  
Factor Ix ◽  
Japanese Subject ◽  
Phase 3 ◽  
Fc Fusion Protein ◽  
Recombinant Factor Ix ◽  
Long Acting

scholarly journals Long‐acting recombinant factor IX Fc fusion protein ( rFIXF c) for perioperative management of subjects with haemophilia B in the phase 3 B‐LONG study

2014 ◽  
Vol 168 (1) ◽  
pp. 124-134 ◽  
Author(s):  
Jerry S. Powell ◽  
Shashikant Apte ◽  
Hervé Chambost ◽  
Cedric Hermans ◽  
Shannon Jackson ◽  
...  
Keyword(s):  
Fusion Protein ◽  
Perioperative Management ◽  
Factor Ix ◽  
Phase 3 ◽  
Haemophilia B ◽  
Fc Fusion Protein ◽  
Recombinant Factor Ix ◽  
Long Acting

scholarly journals Long-term safety and efficacy of extended-interval prophylaxis with recombinant factor IX Fc fusion protein (rFIXFc) in subjects with haemophilia B

2017 ◽  
Vol 117 (03) ◽  
pp. 508-518 ◽  
Author(s):  
K.John Pasi ◽  
Kathelijn Fischer ◽  
Margaret Ragni ◽  
Beatrice Nolan ◽  
David J. Perry ◽  
...  
Keyword(s):  
Fusion Protein ◽  
Factor Ix ◽  
Safety And Efficacy ◽  
Haemophilia B ◽  
Treatment Groups ◽  
Fc Fusion Protein ◽  
Recombinant Factor Ix ◽  
Bleeding Episodes ◽  
Supplementary Material

SummaryThe safety, efficacy, and prolonged half-life of recombinant factor IX Fc fusion protein (rFIXFc) were demonstrated in the Phase 3 B-LONG (adults/adolescents ≥12 years) and Kids B-LONG (children <12 years) studies of subjects with haemophilia B (≤2 IU/dl). Here, we report interim, long-term safety and efficacy data from B-YOND, the rFIXFc extension study. Eligible subjects who completed B-LONG or Kids B-LONG could enrol in B-YOND. There were four treatment groups: weekly prophylaxis (20–100 IU/kg every 7 days), individualised prophylaxis (100 IU/kg every 8–16 days), modified prophylaxis (further dosing personalisation to optimise prophylaxis), and episodic (ondemand) treatment. Subjects could change treatment groups at any point. Primary endpoint was inhibitor development. One hundred sixteen subjects enrolled in B-YOND. From the start of the parent studies to the B-YOND interim data cut, median duration of rFIXFc treatment was 39.5 months and 21.9 months among adults/adolescents and children, respectively; 68/93 (73.1 %) adults/adolescents and 9/23 (39.1 %) children had ≥100 cumulative rFIXFc exposure days. No inhibitors were observed. Median annualised bleeding rates (ABRs) were low in all prophylaxis regimens: weekly (≥12 years: 2.3; <6 years: 0.0; 6 to <12 years: 2.7), individualised (≥12 years: 2.3; 6 to <12 years: 2.4), and modified (≥12 years: 2.4). One or two infusions were sufficient to control 97 % (adults/adolescents) and 95 % (children) of bleeding episodes. Interim data from B-YOND are consistent with data from B-LONG and Kids B-LONG, and confirm the longterm safety of rFIXFc, absence of inhibitors, and maintenance of low ABRs with prophylactic dosing every 1 to 2 weeks.Supplementary Material to this article is available online at www.thrombosis-online.com.

scholarly journals Switching to recombinant factor IX Fc fusion protein prophylaxis results in fewer infusions, decreased factor IX consumption and lower bleeding rates

2014 ◽  
Vol 168 (1) ◽  
pp. 113-123 ◽  
Author(s):  
Jerry Powell ◽  
Amy Shapiro ◽  
Margaret Ragni ◽  
Claude Negrier ◽  
Jerzy Windyga ◽  
...  
Keyword(s):  
Fusion Protein ◽  
Factor Ix ◽  
Fc Fusion Protein ◽  
Recombinant Factor Ix

Idelvion® as a modern treatment option for haemophilia B (Sponsor: CSL Behring GmbH)

2020 ◽  
Vol 12 (01) ◽  
pp. 1-20
Keyword(s):  
Fusion Protein ◽  
Safety Profile ◽  
Factor Ix ◽  
Efficacy And Safety ◽  
Haemophilia B ◽  
Previous Therapy ◽  
Injection Frequency ◽  
Recombinant Factor Ix ◽  
Modern Treatment ◽  
Long Acting

ZusammenfassungIdelvion® (albutrepenonacog alfa, rIX-FP) is a long-acting recombinant factor IX (FIX) albumin fusion protein indicated for the treatment and prophylaxis of bleeding in patients with haemophilia B. It allows prophylaxis intervals of up to 14 days.* Compared with previous therapy, this fusion protein allows for a significant reduction in injection frequency while maintaining a favourable efficacy and safety profile.

scholarly journals Favorable pharmacokinetics in hemophilia B for nonacog beta pegol versus recombinant factor IX-Fc fusion protein: A randomized trial

2019 ◽  
Vol 3 (2) ◽  
pp. 268-276 ◽  
Author(s):  
Carmen Escuriola Ettingshausen ◽  
Inga Hegemann ◽  
Mindy L. Simpson ◽  
Adam Cuker ◽  
Roshni Kulkarni ◽  
...  
Keyword(s):  
Fusion Protein ◽  
Randomized Trial ◽  
Protein A ◽  
Factor Ix ◽  
Hemophilia B ◽  
Fc Fusion Protein ◽  
Recombinant Factor Ix

Recombinant factor IX Fc fusion protein in children with haemophilia B (Kids B-LONG): results from a multicentre, non-randomised phase 3 study

2017 ◽  
Vol 4 (2) ◽  
pp. e75-e82 ◽  
Author(s):  
Kathelijn Fischer ◽  
Roshni Kulkarni ◽  
Beatrice Nolan ◽  
Johnny Mahlangu ◽  
Savita Rangarajan ◽  
...  
Keyword(s):  
Fusion Protein ◽  
Factor Ix ◽  
Phase 3 ◽  
Haemophilia B ◽  
Fc Fusion Protein ◽  
Recombinant Factor Ix

scholarly journals Phase 3 Study of Recombinant Factor IX Fc Fusion Protein in Hemophilia B

2013 ◽  
Vol 369 (24) ◽  
pp. 2313-2323 ◽  
Author(s):  
Jerry S. Powell ◽  
K. John Pasi ◽  
Margaret V. Ragni ◽  
Margareth C. Ozelo ◽  
Leonard A. Valentino ◽  
...  
Keyword(s):  
Fusion Protein ◽  
Factor Ix ◽  
Hemophilia B ◽  
Phase 3 ◽  
Fc Fusion Protein ◽  
Recombinant Factor Ix
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