{"id":258280,"date":"2024-04-09T09:23:35","date_gmt":"2024-04-09T07:23:35","guid":{"rendered":"https:\/\/www.fqeuskadi.org\/?p=258280"},"modified":"2024-04-09T09:23:42","modified_gmt":"2024-04-09T07:23:42","slug":"4d-710-terapia-genikoaren","status":"publish","type":"post","link":"https:\/\/www.fqeuskadi.org\/eu\/4d-710-terapia-genikoaren\/","title":{"rendered":"FKrako 4D-710 terapia genikoaren 3. faseko saiakuntza 2025. urtearen amaierarako aurreikusten da."},"content":{"rendered":"<p>[et_pb_section fb_built=&#8221;1&#8243; admin_label=&#8221;section&#8221; _builder_version=&#8221;4.16&#8243; global_colors_info=&#8221;{}&#8221;][et_pb_row admin_label=&#8221;row&#8221; _builder_version=&#8221;4.16&#8243; background_size=&#8221;initial&#8221; background_position=&#8221;top_left&#8221; background_repeat=&#8221;repeat&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.16&#8243; custom_padding=&#8221;|||&#8221; global_colors_info=&#8221;{}&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_text _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; hover_enabled=&#8221;0&#8243; sticky_enabled=&#8221;0&#8243;]<\/p>\n<h3 class=\"p1\">Saiakuntzaren emaitzak izan litezke terapia onartzeko eskaeren oinarria.<\/h3>\n<p class=\"p3\"><span class=\"s1\"><a href=\"https:\/\/4dmoleculartherapeutics.com\/\">4D Molekular Therapeutics<\/a><\/span> (4DMT) 3. faseko saiakuntza kliniko bat prestatzen ari da. Emaitzak positiboak badira, konpainiaren 4D-710 terapia geniko inhalatua onartzeko eskaeren oinarria izango da,<b> Fibrosi Kistikoa (FK) duten eta CFTR modulatzaileak hartu ezin dituzten pertsonentzako tratamendu gisa.<\/b><\/p>\n<p class=\"p3\">4DMTk AEBetako eta Europako agintariekin elkarrizketak osatu ditu berriki, eta konpainiak esan du orain <b>bide argi bat<\/b> ikusten duela terapiaren onarpen formala lortzeko moduari buruz.<\/p>\n<p class=\"p3\">Planifikatutako 3. faseko saiakuntzan, birika-funtzio murriztua duten <b>60-80 pertsona <\/b>inskribatzea espero da; zehazki, segundu batean aurreikusitako arnas bolumen bortxatuaren (ppFEV1) ehunekoa <b>%40tik %80ra bitartekoa izatea<\/b>. Ikerketaren <b>helburu nagusietako bat izango da 4D-710 bitarteko tratamenduak ppFEV1-ari nola eragiten dion neurtzea<\/b>. PpFEV1-a birika-funtzioaren neurria da, norbaitek segundo batean indarrez kanporatu dezakeen aire-kopurua neurtzen duena.<\/p>\n<p class=\"p3\">3. faseko azterketan, halaber, gene-terapiak <b>pazienteen bizi-kalitateari nola eragiten dion ebaluatuko da<\/b>, Fibrosi Kistikoari buruzko Galdetegiaren Arnas Eremu Berrikusia (CFQ-R-RD) izeneko eskala estandarraren eta biriketako exazerbazioen maiztasunaren bidez neurtuta.<\/p>\n<h3 class=\"p1\">FKaren kontrako terapia genikoko saiakuntzak egiteko fabrikazio-instalazioak sortzen dira<\/h3>\n<p class=\"p3\">Saiakuntza 2025eko bigarren erdian hastea espero da. 4DMTk esan zuen <b>dagoeneko ezarri dituela entsegurako terapia genetikoa fabrikatzeko instalazioak<\/b>, azkenean onartzen bada produktu komertzial bat fabrikatzeko erabil daitezkeen prozedura berak erabiliz.<\/p>\n<blockquote>\n<p class=\"p3\">4D-710 terapia, <b>CFTR genearen kopia osasungarria birika-zelulei emateko diseinatuta dago,<\/b> eta, horri esker, C<b>FTR proteina funtzional bat sor daiteke.<\/b> 4DMT terapia genetikoa garatzen ari da CFTR modulatzaileak hartu ezin dituzten FKa duten pertsonentzat, dela mutazio hautagarririk ez dutelako, dela modulatzaileak albo-ondorio onartezinak eragiten ari zirelako.<\/p>\n<\/blockquote>\n<p class=\"p3\">Paziente horien tratamenduen behar ase gabea dagoenez, 4DMTk esan zuen<b> 4D-710erako onespen azeleratua bilatzeko aukera aztertzen ari dela<\/b>. Onarpen azeleratua baldintzazko onespena da, enpresei etorkizun handiko datu kliniko goiztiarretan oinarritutako terapia merkaturatzeko aukera ematen diena. Enpresak proba gehiago egitearen baldintzarekin, terapia eraginkorra dela frogatzeko.<\/p>\n<p><a href=\"https:\/\/cysticfibrosisnewstoday.com\/news\/phase-3-trial-cf-gene-therapy-ad-710-planned-late-2025\/\">Jatorrizko albistea<\/a><\/p>\n<p>Beste albistez batzuk: <a href=\"https:\/\/www.fqeuskadi.org\/eu\/bixi-plataforma-berria\/\" target=\"_blank\" rel=\"noopener\">BIXI: FIBROSI KISTIKOA DUTEN FAMILIENTZAT BALIABIDEAK LORTZEKO SORTU DEN PLATAFORMA BERRIA<\/a><\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Saiakuntzaren emaitzak izan litezke terapia onartzeko eskaeren oinarria. 4D Molekular Therapeutics (4DMT) 3. faseko saiakuntza kliniko bat prestatzen ari da. Emaitzak positiboak badira, konpainiaren 4D-710 terapia geniko inhalatua onartzeko eskaeren oinarria izango da, Fibrosi Kistikoa (FK) duten eta CFTR modulatzaileak hartu ezin dituzten pertsonentzako tratamendu gisa. 4DMTk AEBetako eta Europako agintariekin elkarrizketak osatu ditu berriki, [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":258278,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"categories":[47],"tags":[],"class_list":["post-258280","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-fq-berriak"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.9 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>4D-710 terapia genikoaren 3. faseko saiakuntza 2025an - FQ EUSKADI<\/title>\n<meta name=\"description\" content=\"4D-710 terapia geniko inhalatua onartzeko eskaeren oinarria izango da, FKa duten eta CFTR modulatzaileak hartu ezin dituzten pertsonentzako tratamendu gisa.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.fqeuskadi.org\/eu\/4d-710-terapia-genikoaren\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"4D-710 terapia genikoaren 3. faseko saiakuntza 2025an - 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