{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,19]],"date-time":"2026-09-19T10:15:15Z","timestamp":1789812915132,"version":"4.0.1"},"reference-count":25,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2026,6,15]],"date-time":"2026-06-15T00:00:00Z","timestamp":1781481600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,6,15]],"date-time":"2026-06-15T00:00:00Z","timestamp":1781481600000},"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":[[2026,9]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Efanesoctocog alfa (Efa) is a high\u2010sustained factor (F)VIII engineered to overcome von Willebrand factor (VWF)\u2010dependent clearance, enabling once\u2010weekly dosing. However, FVIII activity (FVIII:C) differs between the one\u2010stage assay (OSA) and chromogenic substrate assay (CSA), and its relationship with global assays remains unclear.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Aim<\/jats:title>\n                    <jats:p>To assess the procoagulant potential in people with haemophilia A (PwHA) treated with Efa using conventional and global assays.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Plasma samples were collected from five PwHA treated with Efa. FVIII:C was assayed using OSA (RevohemAPTT, PathromtinSL at two institutions) and CSA. Clot waveform analysis (CWA) using RevohemAPTT SLA and ThromboCheck APTT SLA, thrombin generation assay (TGA), and rotational thromboelastometry were performed. Apparent equivalent FVIII:C (app\u2010eq\u2010FVIII:C) was derived from reference curves for cross\u2010assay comparison.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>OSA\u2010FVIII:C showed reagent\u2010 and site\u2010dependent variability. Pathromtin\u2010based FVIII:C aligned with Revohem\u2010based values at one site but was 1.6\u20131.8\u2010fold higher at the other. CSA values were higher; CSA\/2.5 variably approximated OSA in this dataset. CWA increased consistently after administration, with Revohem\u2010based assays higher than ThromboCheck\u2010based assays, indicating reagent\u2010dependent variation within CWA. TGA showed increased thrombin generation with interpatient variability, ranging from minimal to relatively marked increases; conversion to app\u2010eq\u2010FVIII:C was strongly parameter\u2010dependent (time\u2010to\u2010Peak vs Peak\u2010Th). Rotational thromboelastometry revealed heterogeneous responses, and app\u2010eq\u2010FVIII:C was frequently lower than OSA and CSA\/2.5\u2010derived values.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Efa demonstrated assay\u2010detected post\u2010infusion increases; however, FVIII:C measurement varied across platforms and parameters. In this small exploratory cohort, these findings support assay\u2010specific validation and cautious interpretation of inter\u2010platform differences, rather than definitive conclusions regarding optimal monitoring strategy or direct clinical decision\u2010making.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/hae.70341","type":"journal-article","created":{"date-parts":[[2026,6,15]],"date-time":"2026-06-15T08:59:04Z","timestamp":1781513944000},"page":"1272-1281","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Monitoring of Coagulation Potential of Efanesoctocog Alfa in Haemophilia A: Insights From Conventional and Global Hemostasis Assays"],"prefix":"10.1111","volume":"32","author":[{"given":"Masahiro","family":"Takeyama","sequence":"first","affiliation":[{"name":"Division of Hemophilia National Hospital Organization Osaka National Hospital  Osaka Japan"},{"name":"Department of Pediatrics Nara Medical University  Kashihara Nara Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yasuharu","family":"Nishida","sequence":"additional","affiliation":[{"name":"Division of Hemophilia National Hospital Organization Osaka National Hospital  Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shoko","family":"Furukawa","sequence":"additional","affiliation":[{"name":"Division of Hemophilia National Hospital Organization Osaka National Hospital  Osaka Japan"},{"name":"Department of Pediatrics Nara Medical University  Kashihara Nara Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenichi","family":"Ogiwara","sequence":"additional","affiliation":[{"name":"Department of Pediatrics Nara Medical University  Kashihara Nara Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keiji","family":"Nogami","sequence":"additional","affiliation":[{"name":"Department of Pediatrics Nara Medical University  Kashihara Nara Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,6,15]]},"reference":[{"key":"e_1_2_12_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.14046"},{"key":"e_1_2_12_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140\u20106736(15)01123\u2010X"},{"key":"e_1_2_12_4_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2002699"},{"key":"e_1_2_12_5_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood.2019001292"},{"key":"e_1_2_12_6_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2209226"},{"key":"e_1_2_12_7_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2312611"},{"key":"e_1_2_12_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.14831"},{"key":"e_1_2_12_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.70173"},{"key":"e_1_2_12_10_1","doi-asserted-by":"publisher","DOI":"10.1055\/a\u20102717\u20103413"},{"key":"e_1_2_12_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.70196"},{"issue":"8","key":"e_1_2_12_12_1","doi-asserted-by":"crossref","first-page":"2436","DOI":"10.3324\/haematol.2023.284498","article-title":"Efanesoctocog Alfa: The Renaissance of Factor VIII Replacement Therapy","volume":"109","author":"Dargaud Y.","year":"2024","journal-title":"Haematologica"},{"key":"e_1_2_12_13_1","doi-asserted-by":"publisher","DOI":"10.1160\/TH04-10-0706"},{"key":"e_1_2_12_14_1","doi-asserted-by":"publisher","DOI":"10.1055\/s-0038-1649638"},{"key":"e_1_2_12_15_1","doi-asserted-by":"publisher","DOI":"10.1159\/000071636"},{"key":"e_1_2_12_16_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1538-7836.2003.00075.x"},{"key":"e_1_2_12_17_1","doi-asserted-by":"publisher","DOI":"10.1111\/jth.14022"},{"key":"e_1_2_12_18_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12185-020-02959-x"},{"key":"e_1_2_12_19_1","doi-asserted-by":"publisher","DOI":"10.1002\/pbc.29731"},{"key":"e_1_2_12_20_1","doi-asserted-by":"publisher","DOI":"10.1055\/s-0041-1725009"},{"key":"e_1_2_12_21_1","unstructured":"European Medicines A.ALTUVIIIO (Efanesoctocog Alfa) Summary of Product Characteristics.:(EMA 2023)."},{"key":"e_1_2_12_22_1","unstructured":"U. S. Food and A. Drug ALTUVIIIO (Efanesoctocog Alfa) Prescribing Information. (FDA 2023)."},{"key":"e_1_2_12_23_1","doi-asserted-by":"publisher","DOI":"10.1111\/jth.15741"},{"key":"e_1_2_12_24_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jtha.2024.12.034"},{"key":"e_1_2_12_25_1","doi-asserted-by":"publisher","DOI":"10.3389\/fmed.2015.00062"},{"key":"e_1_2_12_26_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.15131"}],"container-title":["Haemophilia"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/hae.70341","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/hae.70341","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/hae.70341","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,19]],"date-time":"2026-09-19T09:41:39Z","timestamp":1789810899000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/hae.70341"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,6,15]]},"references-count":25,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2026,9]]}},"alternative-id":["10.1111\/hae.70341"],"URL":"https:\/\/doi.org\/10.1111\/hae.70341","archive":["Portico"],"relation":{},"ISSN":["1351-8216","1365-2516"],"issn-type":[{"value":"1351-8216","type":"print"},{"value":"1365-2516","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,6,15]]},"assertion":[{"value":"2026-03-15","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-06-08","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-06-15","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}