{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,8]],"date-time":"2026-10-08T12:40:23Z","timestamp":1791463223301,"version":"4.3.4"},"reference-count":16,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2026,1,4]],"date-time":"2026-01-04T00:00:00Z","timestamp":1767484800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,1,4]],"date-time":"2026-01-04T00:00:00Z","timestamp":1767484800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100004326","name":"Bayer","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004326","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["European J of Haematology"],"published-print":{"date-parts":[[2026,4]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>In the earlier PROTECT VIII Kids study (NCT01775618), damoctocog alfa pegol was efficacious for prevention and treatment of bleeds in children aged &lt;\u200912\u2009years with severe haemophilia A.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>Assess the safety of damoctocog alfa pegol, including hypersensitivity and loss of efficacy (LoE) due to an immune response to polyethylene glycol, in children aged 7 to &lt;\u200912\u2009years with severe haemophilia A.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Alfa\u2010PROTECT is a phase 3, multicentre, open\u2010label, single\u2010arm study (NCT05147662). Primary endpoint was the incidence of adverse events of special interest (AESI) leading to discontinuation during the first 4 exposure days.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Overall, 35 children enrolled; 32 completed the 6\u2010month study, 21 (60%) reported \u2265\u20091 AE. Median (range) treatment duration was 182 (172\u2013198) days. All AEs were mild\/moderate; 3\/35 children (8.6%) had study drug\u2010related AEs. One (2.9%) LoE event was considered an AESI, and led to temporary treatment interruption. No AEs resulted in study drug discontinuation. The probability of &lt;\u20095% of patients experiencing an AESI was 92.2%. Bleed protection was maintained with damoctocog alfa pegol prophylaxis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>These data confirm the safety profile of damoctocog alfa pegol in children aged 7 to &lt;\u200912\u2009years with severe haemophilia A. Secondary endpoints indicate treatment was efficacious.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial Registration<\/jats:title>\n                    <jats:p>\n                      The Alfa\u2010PROTECT trial is registered at\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"https:\/\/clinicaltrials.gov\/study\/NCT05147662\">ClinicalTrial.gov<\/jats:ext-link>\n                      (NCT05147662)\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/ejh.70059","type":"journal-article","created":{"date-parts":[[2026,1,5]],"date-time":"2026-01-05T05:41:26Z","timestamp":1767591686000},"page":"435-442","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Safety and Efficacy of Damoctocog Alfa Pegol in Previously Treated Children Aged 7 to &lt;\u200912\u2009Years With Severe Haemophilia A in the Phase 3, Open Label Alfa\u2010\n                    <scp>PROTECT<\/scp>\n                    Main Study"],"prefix":"10.1111","volume":"116","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5938-0675","authenticated-orcid":false,"given":"Margareth C.","family":"Ozelo","sequence":"first","affiliation":[{"name":"University of Campinas, Hemocentro UNICAMP  Campinas S\u00e3o Paulo Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6939-3047","authenticated-orcid":false,"given":"Matteo","family":"Luciani","sequence":"additional","affiliation":[{"name":"Bambino Ges\u00f9 Children's Hospital  Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1153-4131","authenticated-orcid":false,"given":"Heidi","family":"Glosli","sequence":"additional","affiliation":[{"name":"National Center for Rare Disorders and Department of Paediatric Research Oslo University Hospital  Oslo Norway"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4910-2142","authenticated-orcid":false,"given":"Kaan","family":"Kavakli","sequence":"additional","affiliation":[{"name":"Department of Pediatrics Ege University Faculty of Medicine  Bornova Turkey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6754-1261","authenticated-orcid":false,"given":"Nasrin","family":"Samji","sequence":"additional","affiliation":[{"name":"Department of Pediatrics McMaster Centre for Transfusion Research, McMaster Children's Hospital\/McMaster University  Hamilton Ontario Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3437-621X","authenticated-orcid":false,"given":"Gregory C.","family":"Makris","sequence":"additional","affiliation":[{"name":"Bayer AG  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claudia","family":"Tueckmantel","sequence":"additional","affiliation":[{"name":"Bayer AG  Wuppertal Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0000-4320-6349","authenticated-orcid":false,"given":"Monika","family":"Maas Enriquez","sequence":"additional","affiliation":[{"name":"Bayer AG  Wuppertal Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9845-0864","authenticated-orcid":false,"given":"Luciana C.","family":"Oliveira","sequence":"additional","affiliation":[{"name":"Hemocentro de Ribeir\u00e3o Preto, University of S\u00e3o Paulo  Ribeir\u00e3o Preto S\u00e3o Paulo Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shveta","family":"Gupta","sequence":"additional","affiliation":[{"name":"Arnold Palmer Hospital for Children  Orlando Florida USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0001-2166-6587","authenticated-orcid":false,"given":"Mario Guillermo","family":"Arbes\u00fa","sequence":"additional","affiliation":[{"name":"Arbes\u00fa Hematolog\u00eda  Mendoza Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0584-1901","authenticated-orcid":false,"given":"Mauro","family":"Davoli","sequence":"additional","affiliation":[{"name":"Fundaci\u00f3n de la Hemofilia  Rosario Santa Fe Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1551-3995","authenticated-orcid":false,"given":"Anthony K. 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