{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,28]],"date-time":"2026-10-28T00:18:39Z","timestamp":1793146719638,"version":"4.5.0"},"reference-count":39,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2025,7,17]],"date-time":"2025-07-17T00:00:00Z","timestamp":1752710400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2025,7,17]],"date-time":"2025-07-17T00:00:00Z","timestamp":1752710400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Haemophilia"],"published-print":{"date-parts":[[2025,9]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Eptacog beta is an activated recombinant human factor VII bypassing agent approved for treating bleeding episodes (BEs) in patients aged \u226512 years with haemophilia A or B with inhibitors. Two initial dose regimens (IDRs) of either 75 or 225\u00a0\u00b5g\/kg, followed by 75\u00a0\u00b5g\/kg, are approved. We examined the safety of eptacog beta 225\u00a0\u00b5g\/kg across completed clinical trials.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This analysis included data from a Phase 1b trial of single doses of eptacog beta 25, 75 and 225\u00a0\u00b5g\/kg in non\u2010bleeding adults with haemophilia and pooled data from two Phase 3 trials of the 75 and 225\u00a0\u00b5g\/kg IDRs for treating BEs in adolescents and adults (PERSEPT 1) and children (PERSEPT 2).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>In the Phase 1b trial, 10 patients received a single eptacog beta infusion at each dose level. In the Phase 3 trials, 48 patients received the 75\u00a0\u00b5g\/kg IDR (median 20.5 infusions\/patient, range 1\u2013137 infusions) and 50 patients received the 225\u00a0\u00b5g\/kg IDR (median 14.5 infusions\/patient, range 1\u2013117 infusions). There was a similar incidence of treatment\u2010emergent adverse events (TEAEs) across all doses (225, 75 and 25\u00a0\u00b5g\/kg) in the Phase 1b trial (0.8 vs. 1.0 vs. 2.1 events per infusion, respectively) and with the 225 versus 75 \u00b5g\/kg IDR in the Phase 3 studies (0.046\u00a0vs. 0.029 events per infusion, respectively). No treatment\u2010related serious TEAEs, thromboembolic events, hypersensitivity reactions, deaths attributed to eptacog beta or neutralising antibodies were detected.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>These findings demonstrate favourable safety and tolerability regarding the use of the 225\u00a0\u00b5g\/kg IDR.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial Registration<\/jats:title>\n                    <jats:p>ClinicalTrials.gov identifier: NCT01708564, NCT02020369, NCT02448680<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/hae.70083","type":"journal-article","created":{"date-parts":[[2025,7,17]],"date-time":"2025-07-17T16:59:22Z","timestamp":1752771562000},"page":"957-965","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Safety and Use of Eptacog Beta 225 \u00b5g\/kg in Patients With Haemophilia A or B With Inhibitors"],"prefix":"10.1111","volume":"31","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5350-1763","authenticated-orcid":false,"given":"Manuel","family":"Carcao","sequence":"first","affiliation":[{"name":"The Hospital for Sick Children  Toronto Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5429-8437","authenticated-orcid":false,"given":"C\u00e9dric","family":"Hermans","sequence":"additional","affiliation":[{"name":"Catholic University of Louvain Hemophilia Center of the Saint\u2010Luc University Hospital  Brussels Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adam","family":"Giermasz","sequence":"additional","affiliation":[{"name":"UC Davis Medical Center  Sacramento California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0599-5724","authenticated-orcid":false,"given":"Craig","family":"Kessler","sequence":"additional","affiliation":[{"name":"Lombardi Comprehensive Cancer Center Georgetown University Medical Center  Washington USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4506-0061","authenticated-orcid":false,"given":"Wolfgang","family":"Miesbach","sequence":"additional","affiliation":[{"name":"Goethe University Hospital  Frankfurt Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9148-3268","authenticated-orcid":false,"given":"Doris","family":"Quon","sequence":"additional","affiliation":[{"name":"Orthopaedic Hemophilia Treatment Center  Los Angeles USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7877-4784","authenticated-orcid":false,"given":"Jerzy","family":"Windyga","sequence":"additional","affiliation":[{"name":"Institute of Hematology and Transfusion Medicine  Warsaw Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5781-7669","authenticated-orcid":false,"given":"Johnny","family":"Mahlangu","sequence":"additional","affiliation":[{"name":"University of the Witwatersrand  Johannesburg South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,7,17]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/s0140\u20106736(20)32722\u20107"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/bjh.14610"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.3324\/haematol.2019.239160"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/jth.14296"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.3324\/haematol.2022.282099"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.14046"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1538\u20107836.2004.00759.x"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.thromres.2009.11.027"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1538\u20107836.2006.01772.x"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365\u20102516.2007.01601.x"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1160\/TH05-07-0510"},{"key":"e_1_2_10_13_1","unstructured":"NovoSeven: Summary of Product Characteristics published February 27 2023 accessed October 2024 https:\/\/www.ema.europa.eu\/en\/documents\/product\u2010information\/novoseven\u2010epar\u2010product\u2010information_en.pdf."},{"key":"e_1_2_10_14_1","unstructured":"R. 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