
{"id":258291,"date":"2024-04-16T12:40:51","date_gmt":"2024-04-16T10:40:51","guid":{"rendered":"https:\/\/www.fqeuskadi.org\/?p=258291"},"modified":"2024-04-16T12:40:57","modified_gmt":"2024-04-16T10:40:57","slug":"kalydeco-segurua-da-hilabete-bateko-fka-duten-haurretan-3-faseko-saiakuntza","status":"publish","type":"post","link":"https:\/\/www.fqeuskadi.org\/eu\/kalydeco-segurua-da-hilabete-bateko-fka-duten-haurretan-3-faseko-saiakuntza\/","title":{"rendered":"Kalydeco segurua da hilabete bateko FKa duten haurretan: 3. faseko saiakuntza"},"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\">FDAk adin horretako haurrentzako terapiaren erabilera handitu zuen iaz<\/h3>\n<p class=\"p3\"><span class=\"s1\"><a href=\"https:\/\/cysticfibrosisnewstoday.com\/kalydeco-ivacaftor\/\">Kalydeco (ivacaftor)<\/a><\/span> , CFTR terapia modulatzailea, <b>modu seguruan<\/b> administra dakieke Fibrosi Kistikoa (FK) duten 4 asteko haurrei, 3. faseko saiakuntza kliniko baten datuen arabera.<\/p>\n<p class=\"p3\">Aurkikuntzak izan ziren AEBetako Elikagaien eta Sendagaien Administrazioak (FDA)<span class=\"Apple-converted-space\">\u00a0 <\/span>iaz hartutako erabakiaren oinarria, hain zuzen ere, <b>Kalydecoren onarpena zabaltzea adin-tarte horretako haurrentzat.<\/b> Europan ere terapia adin tarte honetarako ere <a href=\"https:\/\/cysticfibrosisnewstoday.com\/news\/ema-committee-supports-cf-therapy-kalydeco-children-1-month-old\/\"><span class=\"s1\">gomendatu zen<\/span><\/a>; izan ere, 4 hilabetetik gorako haurrentzat onartuta dago.<\/p>\n<blockquote>\n<p class=\"p3\"><b>&#8220;Hau une handia da Fibrosi Kistikoarentzat&#8221;<\/b>, esan zuen prentsa-ohar batean Paul McNally doktoreak, Irlandako Royal College of Surgeons-en ikerketaren egilekideak. &#8220;Urteetan zehar, Ivacaftor edo Kalydeco medikamenduaren inguruko saiakuntza klinikoak egin zaizkie gero eta <b>haur txikiagoei.<\/b> Orain, ikerketa honen bidez, frogatu da<b> segurua eta eraginkorra <\/b>dela lau aste bete arte&#8221;.<\/p>\n<\/blockquote>\n<p class=\"p3\">Fibrosi Kistikoa, CFTR proteina sortzeko jarraibideak ematen dituen genean gertatzen diren <b>mutazioek eragiten dute<\/b>. CFTR proteinak zelulen gainazalean ate bat bezala funtzionatzen du normalean, eta <b>zeluletatik sartzen eta irteten den kloruro-fluxua erregulatzen laguntzen du<\/b>. FKa eragiten duten mutazio batzuen ondorioz, atea itxita geratzen da eta proteinak ezin du funtzionatu. Kalydecok atea irekitzeko eta mutazio hautagarriak dituzten pazienteen <b>CFTR funtzioa berrezartzeko<\/b> lan egiten du.<\/p>\n<p class=\"p3\"><b>ARRIVAL<\/b> (NCT02725567), 3. faseko saiakuntza klinikoak, Kalydeco probatu zuen mutazio hautagarriek eragindako FKa zuten<b> 2 urtetik beherako hainbat ume-taldetan<\/b>. Ikerketak emaitza konkretuak eman zituen tratamendua hasi zutenean 1-3 hilabete zituzten zazpi haurtxoko taldearen kasuan. Jaioberrien FK detekzio-probak errutina bat diren herrialdeetan, haur gehienak oso goiz diagnostikatzen dira bizitzan, esan zuen McNallyk.<\/p>\n<p class=\"p3\">Kalydekoren hasierako dosia<b> pisuaren arabera zehaztu zen<\/b>. Hiru haur 5,7 mg-rekin hasi ziren 12 ordutik behin, eta beste laurak 11,4 mg-rekin hasi ziren 12 ordutik behin.<\/p>\n<h3 class=\"p4\"><b>ARRIVAL azterketaren emaitzak<\/b><\/h3>\n<p class=\"p3\">Ikerketaren helburu nagusia <b>segurtasuna ebaluatzea izan zen, eta emaitzak positiboak <\/b>izan ziren; ez zen bigarren mailako ondorio larririk jakinarazi.<\/p>\n<blockquote>\n<p class=\"p3\">&#8220;Ivacaftor [Kalydeco], oro har, segurua eta ondo onartua izan zen 24 asteko tratamendu-aldian, talde txiki honetan, eta aurkako ondorio guztiak larritasun gutxikoak eta ez larriak izan ziren&#8221;, idatzi zuten ikertzaileek.<\/p>\n<\/blockquote>\n<p class=\"p3\">Ikerketan, <b>FKa jaio zenetekin diagnostikatu zuten munduko lehen haurra<\/b> barne hartzen du. Isaac Mossek, bere arreba Kararekin batera parte hartu zuen estudioan.<\/p>\n<blockquote>\n<p class=\"p3\">&#8220;Bai Kara eta bai Isaac oso ondo daude, eta harrigarria bada ere, ez dute Fibrosi Kistikoaren sintoma tipiko bat bera ere une honetan&#8221;, esan zuen bere ama Debbiek.<\/p>\n<\/blockquote>\n<p><a href=\"https:\/\/cysticfibrosisnewstoday.com\/news\/phase-3-trial-results-kalydeco-safe-cf-babies-young-1-month\/\">Jatorrizko albistea<\/a><\/p>\n<p>Beste albisteak: <a href=\"https:\/\/www.fqeuskadi.org\/eu\/4d-710-terapia-genikoaren\/\" target=\"_blank\" rel=\"noopener\">FKRAKO 4D-710 TERAPIA GENIKOAREN 3. FASEKO SAIAKUNTZA 2025. URTEAREN AMAIERARAKO AURREIKUSTEN DA.<\/a><\/p>\n<p>&nbsp;<\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"<p>FDAk adin horretako haurrentzako terapiaren erabilera handitu zuen iaz Kalydeco (ivacaftor) , CFTR terapia modulatzailea, modu seguruan administra dakieke Fibrosi Kistikoa (FK) duten 4 asteko haurrei, 3. faseko saiakuntza kliniko baten datuen arabera. Aurkikuntzak izan ziren AEBetako Elikagaien eta Sendagaien Administrazioak (FDA)\u00a0 iaz hartutako erabakiaren oinarria, hain zuzen ere, Kalydecoren onarpena zabaltzea adin-tarte horretako haurrentzat. [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":258289,"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-258291","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>Kalydeco segurua da hilabete bateko FKa duten haurretan<\/title>\n<meta name=\"description\" content=\"Kalydeco modu seguruan administra dakieke Fibrosi Kistikoa (FK) duten 4 asteko haurrei, 3. faseko saiakuntza kliniko baten datuen arabera.\" \/>\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\/kalydeco-segurua-da-hilabete-bateko-fka-duten-haurretan-3-faseko-saiakuntza\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Kalydeco segurua da hilabete bateko FKa duten haurretan\" \/>\n<meta property=\"og:description\" content=\"Kalydeco modu seguruan administra dakieke Fibrosi Kistikoa (FK) duten 4 asteko haurrei, 3. faseko saiakuntza kliniko baten datuen arabera.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.fqeuskadi.org\/eu\/kalydeco-segurua-da-hilabete-bateko-fka-duten-haurretan-3-faseko-saiakuntza\/\" \/>\n<meta property=\"og:site_name\" content=\"FQ EUSKADI - 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