{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,8]],"date-time":"2026-03-08T15:15:11Z","timestamp":1772982911345,"version":"3.50.1"},"reference-count":42,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2024,1,9]],"date-time":"2024-01-09T00:00:00Z","timestamp":1704758400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2024,1,9]],"date-time":"2024-01-09T00:00:00Z","timestamp":1704758400000},"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":[[2024,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>The safety and efficacy of the extended half\u2010life factor VIII (FVIII) product damoctocog alfa pegol (BAY 94\u20109027, Jivi\u00ae) has been demonstrated in the PROTECT VIII Kids study (NCT01775618), where male previously\u2010treated patients (PTPs) aged &lt;12\u2009years old with severe haemophilia A and \u2265\u200950 exposure days (EDs) were treated prophylactically. The PROTECT VIII Kids extension study assessed the long\u2010term safety and efficacy of damoctocog alfa pegol in the same population.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Aim<\/jats:title>\n                    <jats:p>To evaluate the long\u2010term impact of damoctocog alfa pegol in a post hoc subgroup analysis of adolescent patients in the PROTECT VIII Kids study and its extension from 12th birthday onwards.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>The current analysis included PTPs aged \u226512\u2009years old, who remained in the extension for \u22656\u2009months following their 12th birthday. The observation period was defined as the time from 12th birthday to the end of the extension period; all data from this birthday were included whether in the main study or extension phase. The main efficacy variable was annualised bleeding rate (ABR) and the main safety variable was the frequency of inhibitor development.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>This subgroup analysis comprised 25 patients. Median observation time after 12th birthday was 3.2\u2009years. Median total\/joint\/spontaneous ABRs in the observation period were 1.7\/0.7\/0.3, respectively. Safety findings were consistent with those reported for the overall study population; no confirmed FVIII inhibitors or anti\u2010drug antibodies were reported.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Damoctocog alfa pegol is efficacious with a favourable safety profile in adolescents with haemophilia A, supporting its long\u2010term use in children and adolescents.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/ejh.14167","type":"journal-article","created":{"date-parts":[[2024,1,9]],"date-time":"2024-01-09T06:14:32Z","timestamp":1704780872000},"page":"756-764","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["A post hoc analysis of\n                    <scp>PROTECT VIII<\/scp>\n                    kids assessing long\u2010term efficacy and safety of damoctocog alfa pegol in adolescents with severe haemophilia\n                    <scp>A<\/scp>"],"prefix":"10.1111","volume":"112","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0178-7947","authenticated-orcid":false,"given":"Sanjay","family":"Ahuja","sequence":"first","affiliation":[{"name":"Rainbow Hemostasis &amp; Thrombosis Center, University Hospitals Rainbow Babies and Children's Hospital Case Western Reserve University School of Medicine  Cleveland Ohio USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9986-4973","authenticated-orcid":false,"given":"Tina","family":"Biss","sequence":"additional","affiliation":[{"name":"Department of Haematology Newcastle upon Tyne Hospitals NHS Foundation Trust  Newcastle upon Tyne UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Monika","family":"Maas Enriquez","sequence":"additional","affiliation":[{"name":"Bayer  Wuppertal Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7113-4028","authenticated-orcid":false,"given":"Maria Elisa","family":"Mancuso","sequence":"additional","affiliation":[{"name":"Center for Thrombosis and Hemorrhagic Diseases IRCCS Humanitas Research Hospital  Rozzano Milan Italy"},{"name":"Humanitas University  Pieve Emanuele Milan Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6864-0598","authenticated-orcid":false,"given":"MacGregor","family":"Steele","sequence":"additional","affiliation":[{"name":"Cumming School of Medicine, Alberta Children's Hospital University of Calgary  Calgary Alberta Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3494-9823","authenticated-orcid":false,"given":"Gili","family":"Kenet","sequence":"additional","affiliation":[{"name":"Israel National Hemophilia Center, Chaim Sheba Medical Center, Tel Hashomer, Israel &amp; The Amalia Biron Thrombosis Research Institute Tel Aviv University  Tel Aviv\u2010Yafo Israel"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2024,1,9]]},"reference":[{"key":"e_1_2_12_2_1","doi-asserted-by":"publisher","DOI":"10.7326\/M19-1208"},{"key":"e_1_2_12_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.14046"},{"key":"e_1_2_12_4_1","doi-asserted-by":"publisher","DOI":"10.1177\/2040620718796429"},{"key":"e_1_2_12_5_1","unstructured":"FDA U.JIVI\u00ae highlights of prescribing information. Accessed November 17 2021. Available fromhttps:\/\/www.fda.gov\/media\/115934\/download2018."},{"key":"e_1_2_12_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/jth.12506"},{"key":"e_1_2_12_7_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2009-11-254755"},{"key":"e_1_2_12_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.14294"},{"key":"e_1_2_12_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/jth.13597"},{"key":"e_1_2_12_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.14297"},{"key":"e_1_2_12_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.13963"},{"key":"e_1_2_12_12_1","unstructured":"PMDA.Report on the deliberation results: Jivi. Accessed September 2021. Available from:https:\/\/www.pmda.go.jp\/files\/000229786.pdf2018."},{"key":"e_1_2_12_13_1","unstructured":"AgencyEM.Jivi summary of product characteristics. Accessed November 17 2021. 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