{"id":4350,"date":"2025-08-19T14:31:34","date_gmt":"2025-08-19T11:31:34","guid":{"rendered":"https:\/\/dmdwarrior.com\/?p=4350"},"modified":"2025-08-19T15:44:33","modified_gmt":"2025-08-19T12:44:33","slug":"itf-therapeutics-launching-a-study-to-evaluate-the-real-world-experience-of-duvyzat-givinostat-in-patients-with-duchenne-muscular-dystrophy","status":"publish","type":"post","link":"https:\/\/dmdwarrior.com\/pt\/itf-therapeutics-launching-a-study-to-evaluate-the-real-world-experience-of-duvyzat-givinostat-in-patients-with-duchenne-muscular-dystrophy\/","title":{"rendered":"A ITF Therapeutics lan\u00e7a um estudo para avaliar a experi\u00eancia real do Duvyzat (Givinostat) em pacientes com distrofia muscular de Duchenne"},"content":{"rendered":"<p class=\"wp-block-paragraph\">O objetivo deste estudo observacional prospectivo (NCT07127978) \u00e9 avaliar a seguran\u00e7a, a tolerabilidade e os resultados funcionais de pacientes com DMD que est\u00e3o iniciando o tratamento oral com Duvyzat (Givinostat) pela primeira vez ou que j\u00e1 iniciaram a terapia h\u00e1 seis meses como parte do tratamento cl\u00ednico padr\u00e3o nos Estados Unidos. Com um per\u00edodo de inscri\u00e7\u00e3o de 24 meses e um m\u00ednimo de dois anos de acompanhamento, espera-se que o estudo dure at\u00e9 cinco anos para os pacientes inicialmente recrutados.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Saber mais<\/strong>: <a href=\"https:\/\/dmdwarrior.com\/pt\/duvyzat-givinostat-nonsteroidal-drug\/\" target=\"_blank\" rel=\"noreferrer noopener\">O que \u00e9 Duvyzat (Givinostat)?<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">O estudo incluir\u00e1 300 participantes (180 pacientes n\u00e3o deambuladores e at\u00e9 120 pacientes deambuladores). Os participantes ser\u00e3o acompanhados por pelo menos dois anos, com dados coletados durante consultas cl\u00ednicas de rotina. As avalia\u00e7\u00f5es incluem par\u00e2metros laboratoriais (por exemplo, contagem de plaquetas, triglicer\u00eddeos), fun\u00e7\u00e3o card\u00edaca e pulmonar, desfechos relatados pelo paciente e escalas de fun\u00e7\u00e3o motora, como a North Star Ambulatory Assessment (NSAA) e a escala de Performance of Upper Limb (PUL).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Estudo Duvyzat (Givinostat) \u2013 NCT07127978 \u2013<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Este estudo avalia a experi\u00eancia real do uso de Givinostat em pacientes com Distrofia Muscular de Duchenne. <\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>In\u00edcio do estudo (estimado)<\/strong>: 2025-09-15<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Conclus\u00e3o prim\u00e1ria (estimada):<\/strong> 2030-06-30<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Conclus\u00e3o do estudo (estimada)<\/strong>: 2030-07-30<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>N\u00famero de participantes (estimado)<\/strong>: 300<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Tipo de estudo<\/strong>: Observacional<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Locais<\/strong>: Ainda n\u00e3o h\u00e1 dados de localiza\u00e7\u00e3o.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Idades eleg\u00edveis para estudo<\/strong>: 6 anos ou mais (crian\u00e7a, adulto, idoso)<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Principais crit\u00e9rios de inclus\u00e3o e exclus\u00e3o. \u2013 <a href=\"https:\/\/clinicaltrials.gov\/study\/NCT07127978\" target=\"_blank\" rel=\"noreferrer noopener\">NCT07127978<\/a> \u2013<\/p>","protected":false},"excerpt":{"rendered":"<p>The purpose of this prospective observational study (NCT07127978) is to assess the safety, tolerability, and functional results of DMD patients who are starting oral Duvyzat (Givinostat) for the first time or who have already begun therapy within six months as part of standard clinical care in the United States. With a 24-month enrollment period and [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":4353,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[27],"tags":[46,47],"class_list":["post-4350","post","type-post","status-publish","format-standard","has-post-thumbnail","category-research","tag-duvyzat","tag-givinostat"],"subtitle":"A ITF Therapeutics examinar\u00e1 300 pacientes com DMD que s\u00e3o novos no tratamento com Duvyzat (Givinostat) ou que iniciaram o tratamento h\u00e1 seis meses para avaliar a seguran\u00e7a, a tolerabilidade e os resultados funcionais.","_links":{"self":[{"href":"https:\/\/dmdwarrior.com\/pt\/wp-json\/wp\/v2\/posts\/4350","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dmdwarrior.com\/pt\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/dmdwarrior.com\/pt\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/pt\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/pt\/wp-json\/wp\/v2\/comments?post=4350"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/pt\/wp-json\/wp\/v2\/posts\/4350\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/pt\/wp-json\/wp\/v2\/media\/4353"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/pt\/wp-json\/wp\/v2\/media?parent=4350"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/pt\/wp-json\/wp\/v2\/categories?post=4350"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/pt\/wp-json\/wp\/v2\/tags?post=4350"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}