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Global Post-Authorization Safety Surveillance Study: real-world data on prophylaxis and on-demand treatment using FEIBA (an activated prothrombin complex concentrate)

This prospective, Post-Authorization Safety Surveillance (PASS) study was carried out in patients with hemophilia A or B and inhibitors treated with FEIBA for 1 year to collect real-world data on safety and effectiveness of FEIBA. The study followed a cohort design and did not make stipulations on t...

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Autores principales: Negrier, Claude, Voisin, Sophie, Baghaei, Fariba, Numerof, Robert, Novack, Aaron, Doralt, Jennifer E., Romanov, Vadim, Gringeri, Alessandro
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Lippincott Williams And Wilkins 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4935538/
https://www.ncbi.nlm.nih.gov/pubmed/26829366
http://dx.doi.org/10.1097/MBC.0000000000000525
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author Negrier, Claude
Voisin, Sophie
Baghaei, Fariba
Numerof, Robert
Novack, Aaron
Doralt, Jennifer E.
Romanov, Vadim
Gringeri, Alessandro
author_facet Negrier, Claude
Voisin, Sophie
Baghaei, Fariba
Numerof, Robert
Novack, Aaron
Doralt, Jennifer E.
Romanov, Vadim
Gringeri, Alessandro
author_sort Negrier, Claude
collection PubMed
description This prospective, Post-Authorization Safety Surveillance (PASS) study was carried out in patients with hemophilia A or B and inhibitors treated with FEIBA for 1 year to collect real-world data on safety and effectiveness of FEIBA. The study followed a cohort design and did not make stipulations on treatment or observation schedule, as it was designed to observe routine medical practices based on physicians’ treatment decisions, including whether patients received on-demand or prophylaxis with FEIBA. The attending physician maintained documentation, including medical records, laboratory reports, adverse event reports, and so on and a subject diary was used. Eighty-one patients were treated with FEIBA at 40 sites in 10 countries over a 4-year period. Sixty-nine patients (85.2%) had hemophilia A, two had (2.5%) hemophilia B, and ten (12.3%) had acquired hemophilia A. At baseline 45 patients (55.6%) were prescribed prophylaxis and 36 (44.6%) on-demand treatment. This study was novel in following safety and effectiveness in ‘real world’ on-demand and prophylactic use of FEIBA, and was able to collect data in these rare patients under routine clinical practice.
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spelling pubmed-49355382016-07-26 Global Post-Authorization Safety Surveillance Study: real-world data on prophylaxis and on-demand treatment using FEIBA (an activated prothrombin complex concentrate) Negrier, Claude Voisin, Sophie Baghaei, Fariba Numerof, Robert Novack, Aaron Doralt, Jennifer E. Romanov, Vadim Gringeri, Alessandro Blood Coagul Fibrinolysis Original Articles This prospective, Post-Authorization Safety Surveillance (PASS) study was carried out in patients with hemophilia A or B and inhibitors treated with FEIBA for 1 year to collect real-world data on safety and effectiveness of FEIBA. The study followed a cohort design and did not make stipulations on treatment or observation schedule, as it was designed to observe routine medical practices based on physicians’ treatment decisions, including whether patients received on-demand or prophylaxis with FEIBA. The attending physician maintained documentation, including medical records, laboratory reports, adverse event reports, and so on and a subject diary was used. Eighty-one patients were treated with FEIBA at 40 sites in 10 countries over a 4-year period. Sixty-nine patients (85.2%) had hemophilia A, two had (2.5%) hemophilia B, and ten (12.3%) had acquired hemophilia A. At baseline 45 patients (55.6%) were prescribed prophylaxis and 36 (44.6%) on-demand treatment. This study was novel in following safety and effectiveness in ‘real world’ on-demand and prophylactic use of FEIBA, and was able to collect data in these rare patients under routine clinical practice. Lippincott Williams And Wilkins 2016-07 2016-01-29 /pmc/articles/PMC4935538/ /pubmed/26829366 http://dx.doi.org/10.1097/MBC.0000000000000525 Text en Copyright © 2016 Wolters Kluwer Health, Inc. All rights reserved. http://creativecommons.org/licenses/by-nc-nd/4.0 This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 License, where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially. http://creativecommons.org/licenses/by-nc-nd/4.0
spellingShingle Original Articles
Negrier, Claude
Voisin, Sophie
Baghaei, Fariba
Numerof, Robert
Novack, Aaron
Doralt, Jennifer E.
Romanov, Vadim
Gringeri, Alessandro
Global Post-Authorization Safety Surveillance Study: real-world data on prophylaxis and on-demand treatment using FEIBA (an activated prothrombin complex concentrate)
title Global Post-Authorization Safety Surveillance Study: real-world data on prophylaxis and on-demand treatment using FEIBA (an activated prothrombin complex concentrate)
title_full Global Post-Authorization Safety Surveillance Study: real-world data on prophylaxis and on-demand treatment using FEIBA (an activated prothrombin complex concentrate)
title_fullStr Global Post-Authorization Safety Surveillance Study: real-world data on prophylaxis and on-demand treatment using FEIBA (an activated prothrombin complex concentrate)
title_full_unstemmed Global Post-Authorization Safety Surveillance Study: real-world data on prophylaxis and on-demand treatment using FEIBA (an activated prothrombin complex concentrate)
title_short Global Post-Authorization Safety Surveillance Study: real-world data on prophylaxis and on-demand treatment using FEIBA (an activated prothrombin complex concentrate)
title_sort global post-authorization safety surveillance study: real-world data on prophylaxis and on-demand treatment using feiba (an activated prothrombin complex concentrate)
topic Original Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4935538/
https://www.ncbi.nlm.nih.gov/pubmed/26829366
http://dx.doi.org/10.1097/MBC.0000000000000525
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