{"id":37251,"date":"2022-05-06T15:36:58","date_gmt":"2022-05-06T19:36:58","guid":{"rendered":"https:\/\/wfh.org\/pfizer-sangamo-therapeutics-report-severe-adverse-event-sae-from-phase-3-affine-haemophilia-a-gene-therapy-study\/"},"modified":"2024-04-12T14:19:56","modified_gmt":"2024-04-12T18:19:56","slug":"pfizer-sangamo-therapeutics-report-severe-adverse-event-sae-from-phase-3-affine-haemophilia-a-gene-therapy-study","status":"publish","type":"post","link":"https:\/\/wfh.org\/es\/article\/pfizer-sangamo-therapeutics-report-severe-adverse-event-sae-from-phase-3-affine-haemophilia-a-gene-therapy-study\/","title":{"rendered":"Pfizer\/Sangamo Therapeutics reporta evento adverso grave durante la fase 3 del estudio AFFINE de terapia g\u00e9nica para la hemofilia A"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"37251\" class=\"elementor elementor-37251 elementor-36613\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-487fc85 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"487fc85\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-ea3f908\" data-id=\"ea3f908\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-aa6c1e1 gallery-spacing-custom elementor-widget elementor-widget-image-gallery\" data-id=\"aa6c1e1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image-gallery.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-image-gallery\">\n\t\t\t<div id='gallery-1' class='gallery galleryid-37251 gallery-columns-3 gallery-size-full'><figure class='gallery-item'>\n\t\t\t<div class='gallery-icon landscape'>\n\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"770\" height=\"350\" src=\"https:\/\/wfh.org\/wp-content\/uploads\/2022\/01\/EHC.png\" class=\"attachment-full size-full\" alt=\"Logo del European Haemophilia Consortium\" srcset=\"https:\/\/wfh.org\/wp-content\/uploads\/2022\/01\/EHC.png 770w, https:\/\/wfh.org\/wp-content\/uploads\/2022\/01\/EHC-300x136.png 300w, https:\/\/wfh.org\/wp-content\/uploads\/2022\/01\/EHC-768x349.png 768w\" sizes=\"(max-width: 770px) 100vw, 770px\" \/>\n\t\t\t<\/div><\/figure><figure class='gallery-item'>\n\t\t\t<div class='gallery-icon landscape'>\n\t\t\t\t<img decoding=\"async\" width=\"600\" height=\"300\" src=\"https:\/\/wfh.org\/wp-content\/uploads\/2021\/12\/NHF-logo.png\" class=\"attachment-full size-full\" alt=\"\" srcset=\"https:\/\/wfh.org\/wp-content\/uploads\/2021\/12\/NHF-logo.png 600w, https:\/\/wfh.org\/wp-content\/uploads\/2021\/12\/NHF-logo-300x150.png 300w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/>\n\t\t\t<\/div><\/figure><figure class='gallery-item'>\n\t\t\t<div class='gallery-icon landscape'>\n\t\t\t\t<img decoding=\"async\" width=\"1277\" height=\"603\" src=\"https:\/\/wfh.org\/wp-content\/uploads\/2021\/04\/WFH-trilingual-logo-EN.png\" class=\"attachment-full size-full\" alt=\"\" aria-describedby=\"gallery-1-29976\" srcset=\"https:\/\/wfh.org\/wp-content\/uploads\/2021\/04\/WFH-trilingual-logo-EN.png 1277w, https:\/\/wfh.org\/wp-content\/uploads\/2021\/04\/WFH-trilingual-logo-EN-192x91.png 192w, https:\/\/wfh.org\/wp-content\/uploads\/2021\/04\/WFH-trilingual-logo-EN-768x363.png 768w\" sizes=\"(max-width: 1277px) 100vw, 1277px\" \/>\n\t\t\t<\/div>\n\t\t\t\t<figcaption class='wp-caption-text gallery-caption' id='gallery-1-29976'>\n\t\t\t\tstock\n\t\t\t\t<\/figcaption><\/figure>\n\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e4eb854 elementor-widget elementor-widget-text-editor\" data-id=\"e4eb854\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>El giroctocogene fitelparvovec (SB-525 o PF-07055480), creado por Pfizer\/Sangamo Therapeutics, se utiliza en un ensayo de terapia g\u00e9nica para el tratamiento de la hemofilia A. La fase 3 del estudio AFFINE (<a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04370054\" target=\"_blank\" rel=\"noopener\">NCT04370054<\/a>) es un ensayo multic\u00e9ntrico, de un solo brazo y con etiqueta a la vista a fin de evaluar la eficacia y la seguridad de una sola infusi\u00f3n de giroctocogene fitelparvovec en m\u00e1s de 50 participantes varones adultos (de entre 18 y 64 a\u00f1os de edad) con hemofilia A, de moderada a grave. Se trata de un virus adenoasociado que administra el gene del factor VIII con el dominio B borrado.<\/p>\n<p>&nbsp;<\/p>\n<p>Pfizer inform\u00f3 que el paciente que present\u00f3 la TVP ten\u00eda un historial de eventos tromb\u00f3ticos previos a su participaci\u00f3n en el estudio, un factor de riesgo conocido para eventos subsecuentes y un criterio de exclusi\u00f3n para la participaci\u00f3n en el estudio AFFINE. El participante no deber\u00eda haberse inscrito al estudio, pero ocasionalmente esto puede ocurrir y se conoce como \u201cdesv\u00edo del protocolo\u201d. El caso se valor\u00f3 a fin de comprender todos los posibles factores contribuyentes, entre ellos no haber tomado las dosis de anticoagulantes orales directos recetados por el investigador. El paciente se encuentra bien. Pfizer comparti\u00f3 esta informaci\u00f3n con investigadores del estudio, con autoridades de salud y con el Comit\u00e9 de Monitoreo de Datos externo e independiente. Pfizer tambi\u00e9n respondi\u00f3 preguntas de autoridades de salud. La Federaci\u00f3n Mundial de Hemofilia (FMH), el Consorcio Europeo de Hemofilia (CEH), y la National Hemophilia Foundation (NHF) reportan esta informaci\u00f3n que es del dominio p\u00fablico. El caso podr\u00eda abordarse en el taller sobre seguridad, abastecimiento y acceso de productos de tratamiento, titulado <em>Panorama del tratamiento actual. primera de dos partes: Seguridad y eficacia<\/em>, a realizarse durante el Congreso Mundial 2022 de la FMH, el domingo 8 de mayo.<\/p>\n<p>&nbsp;<\/p>\n<p>En noviembre de 2021, la Administraci\u00f3n de Alimentos y Medicamentos de EE. UU. (FDA, por su sigla en ingl\u00e9s) hab\u00eda suspendido temporalmente el ensayo AFFINE, luego de la suspensi\u00f3n voluntaria por parte de la farmac\u00e9utica, con el prop\u00f3sito de implementar una enmienda al protocolo despu\u00e9s de haber observado niveles de factor VIII mayores a 150% en algunos de los participantes en el ensayo. El objetivo de la enmienda al protocolo era proporcionar directrices para el tratamiento m\u00e9dico de niveles elevados de factor VIII. Poco despu\u00e9s de estos sucesos, en noviembre de 2021, el CEH, la FMH y la NHF <a href=\"https:\/\/www.ehc.eu\/fda-places-the-pfizer-sangamo-therapeutics-phase-3-affine-haemophilia-a-gene-therapy-study-on-clinical-hold\/\">informaron<\/a> de manera conjunta sobre esta suspensi\u00f3n temporal.<\/p>\n<p>&nbsp;<\/p>\n<p>En marzo de 2022, la FDA levant\u00f3 la antes mencionada suspensi\u00f3n temporal de la fase 3 del estudio AFFINE. En ese entonces, Pfizer inform\u00f3 que su pausa temporal permanecer\u00eda vigente hasta satisfacer todas las condiciones, entre ellas la aprobaci\u00f3n por parte de las autoridades reguladoras de los protocolos actualizados del estudio.<\/p>\n<p>&nbsp;<\/p>\n<p>La vigilancia de problemas de seguridad de una nueva tecnolog\u00eda como la terapia g\u00e9nica es fundamental para nuestra comunidad. Con este fin se est\u00e1 creando el Registro de Terapia G\u00e9nica, con el prop\u00f3sito de capturar datos de la mayor\u00eda o de todos los pacientes que reciben terapia g\u00e9nica, conforme estos tratamientos son aprobados para su comercializaci\u00f3n.<\/p>\n<p>&nbsp;<\/p>\n<p>Las tres organizaciones continuar\u00e1n manteniendo informada a nuestra comunidad de pacientes sobre otros acontecimientos relevantes, a fin de apoyar la clara necesidad de un registro mundial para pacientes que se someten a terapia g\u00e9nica y la creaci\u00f3n del mismo, con el prop\u00f3sito de ayudar a diferenciar entre una se\u00f1al de seguridad y un riesgo de fondo.<\/p>\n<p>&nbsp;<\/p>\n<p>Si tuvieran cualquier otra pregunta, recomendamos a nuestros miembros ponerse en contacto con sus m\u00e9dicos tratantes y centros de tratamiento de hemofilia respectivos.<\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7469f87 elementor-widget elementor-widget-spacer\" data-id=\"7469f87\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>5 de mayo de 2022 \u2013 Pfizer\/Sangamo report\u00f3 un evento adverso grave consistente en una trombosis venosa profunda (TVP) por debajo de la rodilla en uno de los participantes en su ensayo cl\u00ednico con giroctocogene fitelparvovec, quien presentaba niveles elevados de factor VIII. Evento adverso grave (EAG) es el t\u00e9rmino usado para describir la ocurrencia de un problema de salud serio durante un estudio, independientemente de que el tratamiento bajo investigaci\u00f3n pudiera haber causado el problema.<\/p>\n","protected":false},"author":3,"featured_media":30516,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[121],"tags":[],"search-category":[85],"class_list":["post-37251","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-declaraciones-y-notificaciones-de-la-fmh","search-category-article"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.2 (Yoast SEO v27.2) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Pfizer\/Sangamo Therapeutics reporta evento adverso grave durante la fase 3 del estudio AFFINE de terapia g\u00e9nica para la hemofilia A | FMH - Federaci\u00f3n Mundial de Hemofilia<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/wfh.org\/es\/article\/pfizer-sangamo-therapeutics-report-severe-adverse-event-sae-from-phase-3-affine-haemophilia-a-gene-therapy-study\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pfizer\/Sangamo Therapeutics reporta evento adverso grave durante la fase 3 del estudio AFFINE de terapia g\u00e9nica para la hemofilia A\" \/>\n<meta property=\"og:description\" content=\"5 de mayo de 2022 \u2013 Pfizer\/Sangamo report\u00f3 un evento adverso grave consistente en una trombosis venosa profunda (TVP) por debajo de la rodilla en uno de los participantes en su ensayo cl\u00ednico con giroctocogene fitelparvovec, quien presentaba niveles elevados de factor VIII. Evento adverso grave (EAG) es el t\u00e9rmino usado para describir la ocurrencia de un problema de salud serio durante un estudio, independientemente de que el tratamiento bajo investigaci\u00f3n pudiera haber causado el problema.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/wfh.org\/es\/article\/pfizer-sangamo-therapeutics-report-severe-adverse-event-sae-from-phase-3-affine-haemophilia-a-gene-therapy-study\/\" \/>\n<meta property=\"og:site_name\" content=\"FMH - Federaci\u00f3n Mundial de Hemofilia\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/wfhemophilia\/\" \/>\n<meta property=\"article:published_time\" content=\"2022-05-06T19:36:58+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-04-12T18:19:56+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/wfh.org\/wp-content\/uploads\/2022\/03\/WFH-statement-News-SP.png\" \/>\n\t<meta property=\"og:image:width\" content=\"2501\" \/>\n\t<meta property=\"og:image:height\" content=\"1459\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Electra Rozakis\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Escrito por\" \/>\n\t<meta name=\"twitter:data1\" content=\"Electra Rozakis\" \/>\n\t<meta name=\"twitter:label2\" content=\"Tiempo de lectura\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minutos\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/wfh.org\/es\/article\/pfizer-sangamo-therapeutics-report-severe-adverse-event-sae-from-phase-3-affine-haemophilia-a-gene-therapy-study\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/wfh.org\/es\/article\/pfizer-sangamo-therapeutics-report-severe-adverse-event-sae-from-phase-3-affine-haemophilia-a-gene-therapy-study\/\"},\"author\":{\"name\":\"Electra Rozakis\",\"@id\":\"https:\/\/wfh.org\/es\/#\/schema\/person\/622f4b0ed56b8e4a987dd20bef774887\"},\"headline\":\"Pfizer\/Sangamo Therapeutics reporta evento adverso grave durante la fase 3 del estudio AFFINE de terapia g\u00e9nica para la hemofilia A\",\"datePublished\":\"2022-05-06T19:36:58+00:00\",\"dateModified\":\"2024-04-12T18:19:56+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/wfh.org\/es\/article\/pfizer-sangamo-therapeutics-report-severe-adverse-event-sae-from-phase-3-affine-haemophilia-a-gene-therapy-study\/\"},\"wordCount\":651,\"publisher\":{\"@id\":\"https:\/\/wfh.org\/es\/#organization\"},\"image\":{\"@id\":\"https:\/\/wfh.org\/es\/article\/pfizer-sangamo-therapeutics-report-severe-adverse-event-sae-from-phase-3-affine-haemophilia-a-gene-therapy-study\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/wfh.org\/wp-content\/uploads\/2022\/03\/WFH-statement-News-SP.png\",\"articleSection\":[\"Declaraciones y notificaciones de la FMH\"],\"inLanguage\":\"es\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/wfh.org\/es\/article\/pfizer-sangamo-therapeutics-report-severe-adverse-event-sae-from-phase-3-affine-haemophilia-a-gene-therapy-study\/\",\"url\":\"https:\/\/wfh.org\/es\/article\/pfizer-sangamo-therapeutics-report-severe-adverse-event-sae-from-phase-3-affine-haemophilia-a-gene-therapy-study\/\",\"name\":\"Pfizer\/Sangamo Therapeutics reporta evento adverso grave durante la fase 3 del estudio AFFINE de terapia g\u00e9nica para la hemofilia A | FMH - 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