{"id":42792,"date":"2020-11-03T19:09:05","date_gmt":"2020-11-04T00:09:05","guid":{"rendered":"https:\/\/wfh.org\/suspendida-la-inscripcion-a-los-ensayos-de-terapia-genica-a-fin-de-evaluar-datos-interinos-takeda\/"},"modified":"2024-04-21T12:42:47","modified_gmt":"2024-04-21T16:42:47","slug":"suspendida-la-inscripcion-a-los-ensayos-de-terapia-genica-a-fin-de-evaluar-datos-interinos-takeda","status":"publish","type":"post","link":"https:\/\/wfh.org\/es\/article\/suspendida-la-inscripcion-a-los-ensayos-de-terapia-genica-a-fin-de-evaluar-datos-interinos-takeda\/","title":{"rendered":"Suspendida la inscripci\u00f3n a los ensayos de terapia g\u00e9nica, a fin de evaluar datos interinos: Takeda"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"42792\" class=\"elementor elementor-42792 elementor-16407\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-de69241 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"de69241\" 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-2e8fb4d\" data-id=\"2e8fb4d\" 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-0d39d9f elementor-widget elementor-widget-text-editor\" data-id=\"0d39d9f\" 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 class=\"\">Takeda suspendi\u00f3 la selecci\u00f3n y una mayor inscripci\u00f3n a los estudios cl\u00ednicos de sus terapias g\u00e9nicas con VAA8 para el tratamiento de las hemofilias A y B. La decisi\u00f3n no es resultado de ninguna preocupaci\u00f3n de seguridad respecto a TAK-754 y TAK-748, sostuvo Takeda en su carta de notificaci\u00f3n a la FMH. \u201cActualmente estamos valorando los datos interinos de la fase 1\/2 en curso del estudio TAK-754 para la hemofilia A, junto con todo el panorama general actual de la terapia g\u00e9nica para la hemofilia\u201d, escribi\u00f3 Takeda. Las personas ya inscritas continuar\u00e1n bajo una estrecha observaci\u00f3n cl\u00ednica, de acuerdo con el protocolo del estudio, y se preparar\u00e1 la transici\u00f3n de aquellas a quienes se planeaba inscribir a estos estudios. Ning\u00fan paciente ha recibido dosis como parte de la fase 1\/2 del estudio TAK-748 para la hemofilia B. Takeda proporcionar\u00e1 informaci\u00f3n actualizada a la comunidad una vez que su valoraci\u00f3n haya concluido.<\/p>\r\n\r\n<p class=\"\">Lea la carta de Takeda, en ingl\u00e9s, aqu\u00ed:<\/p>\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-c5de3da elementor-widget elementor-widget-text-editor\" data-id=\"c5de3da\" 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 class=\"\">19 August 2020<\/p>\r\n\r\n<p class=\"\">TAK-754 and TAK-748 Clinical Studies<\/p>\r\n\r\n<p class=\"\">As one of our partners we work closely with, we are writing today to share an important update with you on Takeda\u2019s gene therapy in hematology. Takeda has recently made the decision to suspend screening and further enrollment in the TAK-754 and TAK-748 clinical studies, effective immediately.<\/p>\r\n\r\n<p class=\"\">As you may know, TAK-754 is an AAV8 gene therapy for the treatment of hemophilia A currently in Phase 1\/2 clinical development, while TAK-748 is an AAV8 gene therapy for the treatment of hemophilia B in Phase 1\/2 study start-up (no subject dosed as of today). In order to determine the most appropriate way forward for both TAK-754 and TAK-748, we are currently assessing the interim data from the ongoing Phase 1\/2 study of TAK-754 in hemophilia A, together with the overall current gene therapy landscape in hemophilia. We will communicate more details on these results to the community in due time once our assessment has been finalized. It is important to note that this decision is not a result of any safety concerns with TAK-754 and TAK-748.<\/p>\r\n\r\n<p class=\"\">We have informed those investigators who are working directly on these studies. Our priority first and foremost, is to ensure the safety and wellbeing of patients. Those who are enrolled will continue to be under close clinical observation according to study protocol, and those who were planned to be enrolled into these studies will be informed and transitioned. We would like to emphasize that we remain committed to advancing gene therapies and very much believe in their potential. Our strategy is focused on delivering novel and transformative medicines to patients, and we will continue to work with our gene therapy platforms with the aim of delivering treatments in the future that can help make a meaningful difference in those living with hemophilia and other rare hematological diseases. We hope to continue the dialogue with your organization to help us inform that innovative focus.<\/p>\r\n\r\n<p class=\"\">We are proud to be a long-standing leader in bleeding disorders, and of our relation with the World Federation of Hemophilia of almost 30 years, which is grounded in our common goal to improve standards of care around the world. Takeda\u2019s vision for a bleed-free world continues to fuel our passion every day to make a difference in the lives of those affected by bleeding disorders. Working together we hope to achieve it.<\/p>\t\t\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>Takeda suspendi\u00f3 la selecci\u00f3n y una mayor inscripci\u00f3n a los estudios cl\u00ednicos de sus terapias g\u00e9nicas con VAA8 para el tratamiento de las hemofilias A y B. La decisi\u00f3n no [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":19564,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[231],"tags":[],"search-category":[],"class_list":["post-42792","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-gene-therapy-es"],"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>Suspendida la inscripci\u00f3n a los ensayos de terapia g\u00e9nica, a fin de evaluar datos interinos: Takeda | 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\/suspendida-la-inscripcion-a-los-ensayos-de-terapia-genica-a-fin-de-evaluar-datos-interinos-takeda\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Suspendida la inscripci\u00f3n a los ensayos de terapia g\u00e9nica, a fin de evaluar datos interinos: Takeda\" \/>\n<meta property=\"og:description\" content=\"Takeda suspendi\u00f3 la selecci\u00f3n y una mayor inscripci\u00f3n a los estudios cl\u00ednicos de sus terapias g\u00e9nicas con VAA8 para el tratamiento de las hemofilias A y B. 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