Cargando…

Results of a phase I/II open-label, safety and efficacy trial of coagulation factor IX (recombinant), albumin fusion protein in haemophilia B patients

INTRODUCTION: rIX-FP is a coagulation factor IX (recombinant), albumin fusion protein with more than fivefold half-life prolongation over other standard factor IX (FIX) products available on the market. AIM: This prospective phase II, open-label study evaluated the safety and efficacy of rIX-FP for...

Descripción completa

Detalles Bibliográficos
Autores principales:	Martinowitz, U, Lissitchkov, T, Lubetsky, A, Jotov, G, Barazani-Brutman, T, Voigt, C, Jacobs, I, Wuerfel, T, Santagostino, E
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	John Wiley & Sons, Ltd 2015
Materias:	Original Articles
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4682460/ https://www.ncbi.nlm.nih.gov/pubmed/25990590 http://dx.doi.org/10.1111/hae.12721

Ejemplares similares

Long-Acting Recombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP) in Children: Results of a Phase 3 Trial
por: Kenet, Gili, et al.
Publicado: (2016)

IDEAL study: A real‐world assessment of pattern of use and clinical outcomes with recombinant coagulation factor IX albumin fusion protein (rIX‐FP) in patients with haemophilia B in Italy
por: Tagliaferri, Annarita, et al.
Publicado: (2022)

Long‐term safety and efficacy of rIX‐FP prophylaxis with extended dosing intervals up to 21 days in adults/adolescents with hemophilia B
por: Mancuso, Maria Elisa, et al.
Publicado: (2020)

Performance of a recombinant fusion protein linking coagulation factor IX with recombinant albumin in one‐stage clotting assays
por: Horn, C., et al.
Publicado: (2018)

Half-life–extended recombinant coagulation factor IX–albumin fusion protein is recycled via the FcRn-mediated pathway
por: Chia, Jenny, et al.
Publicado: (2018)

Population Pharmacokinetic Modelling of Recombinant Factor IX Fc Fusion Protein (rFIXFc) in Patients with Haemophilia B
por: Diao, Lei, et al.
Publicado: (2014)

Fusion of engineered albumin with factor IX Padua extends half‐life and improves coagulant activity
por: Lombardi, Silvia, et al.
Publicado: (2021)

Modified Factor VIII and Factor IX recombinant products
por: Santagostino, Elena, et al.
Publicado: (2018)

GlycoPEGylated recombinant factor IX for hemophilia B in context
por: Santagostino, Elena, et al.
Publicado: (2018)

Real-World Utilisation and Bleed Rates in Patients with Haemophilia B Who Switched to Recombinant Factor IX Fusion Protein (rIX-FP): A Retrospective International Analysis
por: Hermans, Cedric, et al.
Publicado: (2020)

Postmarketing safety and effectiveness of recombinant factor IX (nonacog alfa) in Japanese patients with haemophilia B
por: Fukutake, Katsuyuki, et al.
Publicado: (2019)

Real-World Use of Albutrepenonacog Alfa, A Recombinant Coagulation Factor IX Albumin Fusion Protein, for Personalized Prophylaxis in Japanese Individuals With Hemophilia B: A Case Series
por: Nagao, Azusa, et al.
Publicado: (2023)

Physical activity in individuals with haemophilia and experience with recombinant factor VIII Fc fusion protein and recombinant factor IX Fc fusion protein for the treatment of active patients: a literature review and case reports
por: Wang, Michael, et al.
Publicado: (2016)

High adherence to prophylaxis regimens in haemophilia B patients receiving rIX‐FP: Evidence from clinical trials and real‐world practice
por: Mancuso, Maria Elisa, et al.
Publicado: (2020)

Updates in clinical trial data of extended half-life recombinant factor IX products for the treatment of haemophilia B
por: Mahlangu, Johnny N.
Publicado: (2018)

Budget impact analysis of extended half-life recombinant factor IX (rFIXFc) in the treatment of haemophilia B
por: Aiello, Andrea, et al.
Publicado: (2020)

Cost analysis of extended half-life recombinant factor IX products in the treatment of haemophilia B in Italy: an update
por: Aiello, Andrea, et al.
Publicado: (2022)

Recombinant factor IX Fc for major surgery in hemophilia B: factor IX plasma activity levels and effective hemostasis
por: Shapiro, Amy D., et al.
Publicado: (2023)

Recombinant factor VIII Fc fusion protein for the treatment of severe haemophilia A: Final results from the ASPIRE extension study
por: Nolan, Beatrice, et al.
Publicado: (2020)

Treatment and Prevention of Bleeds in Haemophilia Patients with Inhibitors to Factor VIII/IX
por: Rocino, Angiola, et al.
Publicado: (2017)

Biodistribution of recombinant factor IX, extended half-life recombinant factor IX Fc fusion protein, and glycoPEGylated recombinant factor IX in hemophilia B mice
por: van der Flier, Arjan, et al.
Publicado: (2023)

Surgical outcomes in patients with haemophilia A or B receiving extended half‐life recombinant factor VIII and IX Fc fusion proteins: Real‐world experience in the Nordic countries
por: Lehtinen, Anna‐Elina, et al.
Publicado: (2022)

Recombinant FVIIIFc Versus BAY 94-9027 for Treatment of Patients with Haemophilia A: Comparative Efficacy Using a Matching Adjusted Indirect Comparison
por: Hakimi, Zalmai, et al.
Publicado: (2020)

Recombinant biosynthesis of functional human growth hormone and coagulation factor IX in transgenic soybean seeds
por: da Cunha, Nicolau Brito, et al.
Publicado: (2014)

Pharmacological characteristics of a novel, recombinant fusion protein linking coagulation factor VIIa with albumin (rVIIa-FP)
por: Zollner, S, et al.
Publicado: (2014)

Coagulation Factor IX for Hemophilia B Therapy 
por: Orlova, N. A., et al.
Publicado: (2012)

Sustained high trough factor IX activity levels with continued use of rIX‐FP in adult and paediatric patients with haemophilia B
por: Gill, Joan C., et al.
Publicado: (2019)

Consensus statements on vaccination in patients with haemophilia—Results from the Italian haemophilia and vaccinations (HEVA) project
por: Santagostino, Elena, et al.
Publicado: (2019)

octanate(®): over 20 years of clinical experience in overcoming challenges in haemophilia A treatment
por: Klukowska, Anna, et al.
Publicado: (2020)

Health‐related quality of life in paediatric haemophilia B patients treated with rIX‐FP
por: von Mackensen, Sylvia, et al.
Publicado: (2018)

Recombinant proteins in therapeutics: haemophilia treatment as an example
por: Liras, Antonio
Publicado: (2008)

Real‐world data demonstrate improved bleed control and extended dosing intervals for patients with haemophilia B after switching to recombinant factor IX Fc fusion protein (rFIXFc) for up to 5 years
por: Shapiro, Amy, et al.
Publicado: (2020)

Management of surgery in persons with hemophilia A receiving emicizumab prophylaxis: data from a national hemophilia treatment center
por: Cohen, Omri, et al.
Publicado: (2023)

Switching treatments in haemophilia: is there a risk of inhibitor development?
por: Santagostino, Elena, et al.
Publicado: (2015)

Outcome of Clinical Trials with New Extended Half-Life FVIII/IX Concentrates
por: Mancuso, Maria Elisa, et al.
Publicado: (2017)

Recombinant factor VIII Fc for the treatment of haemophilia A
por: Hermans, Cedric, et al.
Publicado: (2021)

Correlation between endogenous VWF:Ag and PK parameters and bleeding frequency in severe haemophilia A subjects during three-times-weekly prophylaxis with rFVIII-FS
por: Lalezari, S, et al.
Publicado: (2014)

The changing face of immune tolerance induction in haemophilia A with the advent of emicizumab
por: Carcao, Manuel, et al.
Publicado: (2019)

Phase 3 Clinical Trial: Perioperative Use of Nonacog Gamma, a Recombinant Factor IX, in Previously Treated Patients With Moderate/Severe Hemophilia B
por: Windyga, Jerzy, et al.
Publicado: (2020)

Target joint resolution in patients with haemophilia A receiving long‐term prophylaxis with BAY 94‐9027
por: Reding, Mark T., et al.
Publicado: (2020)

Cannot write session to /tmp/vufind_sessions/sess_fvd4f3g35ifof22ar404ep45ta