{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,6]],"date-time":"2025-12-06T17:05:24Z","timestamp":1765040724362,"version":"3.37.3"},"reference-count":14,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2017,8,17]],"date-time":"2017-08-17T00:00:00Z","timestamp":1502928000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"Cangene Corporation"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Haemophilia"],"published-print":{"date-parts":[[2018,1]]},"abstract":"Introduction<\/jats:title>Trenonacog alfa (IB<\/jats:styled-content>1001) is a recombinant factor IX<\/jats:styled-content> (rFIX<\/jats:styled-content>) manufactured in Chinese hamster ovary (CHO<\/jats:styled-content>) cells. IB<\/jats:styled-content>1001 was evaluated in a multicentre clinical trial with haemophilia B patients.<\/jats:p><\/jats:sec>Aim<\/jats:title>The aim was to establish IB<\/jats:styled-content>1001 pharmacokinetic non\u2010inferiority to comparator rFIX<\/jats:styled-content>, safety and efficacy in previously treated patients (PTP<\/jats:styled-content>s) with haemophilia B.<\/jats:p><\/jats:sec>Methods<\/jats:title>Subjects were severe or moderately severe haemophilia B adult and adolescent PTP<\/jats:styled-content>s with no history of FIX<\/jats:styled-content> inhibitors.<\/jats:p><\/jats:sec>Results<\/jats:title>IB<\/jats:styled-content>1001 PK<\/jats:styled-content> non\u2010inferiority to comparator rFIX<\/jats:styled-content> was demonstrated through ratio of AUC<\/jats:styled-content>0\u2010\u221e<\/jats:sub> in 32 subjects. IB<\/jats:styled-content>1001 was well tolerated in all 76 treated subjects; the most common adverse drug reaction was headache (2.6% of subjects) and there were no reports of FIX<\/jats:styled-content> inhibitors. Transient non\u2010inhibitory binding FIX<\/jats:styled-content> antibodies and anti\u2010CHO<\/jats:styled-content> cell protein antibodies developed in 21% and 29% of subjects respectively; no safety concerns were associated with development of these antibodies. Prophylaxis (mean duration\u00a0\u00b1\u00a0SD<\/jats:styled-content>: 17.9\u00a0\u00b1\u00a09.6\u00a0months, mean dose: 55.5\u00a0\u00b1\u00a012.9\u00a0IU\/kg, median 1.0 infusion per week) was effective in preventing bleeds (median annual bleed rate: 1.52, interquartile range: 0.0\u20103.46). One or two IB<\/jats:styled-content>1001 infusions resolved 84% of the bleeds, while for 84% of treatments haemostatic efficacy of IB<\/jats:styled-content>1001 was rated excellent or good. IB<\/jats:styled-content>1001 haemostatic efficacy for all 19 major surgeries was rated adequate or better than adequate.<\/jats:p><\/jats:sec>Conclusions<\/jats:title>IB<\/jats:styled-content>1001 is safe and efficacious for treatment of bleeds, routine prophylaxis and perioperative management in haemophilia B patients.<\/jats:p><\/jats:sec>","DOI":"10.1111\/hae.13324","type":"journal-article","created":{"date-parts":[[2017,8,17]],"date-time":"2017-08-17T23:56:39Z","timestamp":1503014199000},"page":"104-112","source":"Crossref","is-referenced-by-count":18,"title":["Pharmacokinetics, safety and efficacy of a recombinant factor IX<\/scp> product, trenonacog alfa in previously treated haemophilia B patients"],"prefix":"10.1111","volume":"24","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6410-1324","authenticated-orcid":false,"given":"P. W.","family":"Collins","sequence":"first","affiliation":[{"name":"Arthur Bloom Haemophilia Centre School of Medicine Cardiff University Cardiff UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"D. V. K.","family":"Quon","sequence":"additional","affiliation":[{"name":"Hemophilia Treatment Center Orthopaedic Hospital Los Angeles CA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7622-7939","authenticated-orcid":false,"given":"M.","family":"Makris","sequence":"additional","affiliation":[{"name":"Department of Haematology Royal Hallamshire Hospital Sheffield UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6690-8586","authenticated-orcid":false,"given":"P.","family":"Chowdary","sequence":"additional","affiliation":[{"name":"Katharine Dormandy Haemophilia Care and Thrombosis Unit Royal Free Hospital NHS Trust London UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"C. L.","family":"Kempton","sequence":"additional","affiliation":[{"name":"Department of Hematology and Medical Oncology Emory University Atlanta GA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"S. J.","family":"Apte","sequence":"additional","affiliation":[{"name":"Sahyadri Specialty Hospital Pune India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M. V.","family":"Ramanan","sequence":"additional","affiliation":[{"name":"Jehangir Clinical Development Centre Jehangir Hospital Pune India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0162-6828","authenticated-orcid":false,"given":"C. R. M.","family":"Hay","sequence":"additional","affiliation":[{"name":"Manchester Haemophilia Comprehensive Care Centre Manchester UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8139-6446","authenticated-orcid":false,"given":"B.","family":"Drobic","sequence":"additional","affiliation":[{"name":"Clinical Research Emergent BioSolutions Canada Inc. Winnipeg MB Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Y.","family":"Hua","sequence":"additional","affiliation":[{"name":"Clinical Research Emergent BioSolutions Canada Inc. Winnipeg MB Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"T. J.","family":"Babinchak","sequence":"additional","affiliation":[{"name":"Clinical Development and Medical Affairs Emergent BioSolutions Inc. Berwyn IL USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"E. D.","family":"Gomperts","sequence":"additional","affiliation":[{"name":"Consultant for Emergent BioSolutions Inc. Montrose CO USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2017,8,17]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.2.4799.1378"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2516.2012.02909.x"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2516.2008.01695.x"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1155\/2016\/7678901"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.12890"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2516.2012.02897.x"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2015-01-528414"},{"issue":"2","key":"e_1_2_9_9_1","first-page":"s17","article-title":"Secondary prophylaxis in adolescent and adult haemophiliacs","volume":"6","author":"Tagliaferri A","year":"2008","journal-title":"Blood Transfus"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2516.2007.01458.x"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.12228"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1177\/2040620714550573"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1305074"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1055\/s-0037-1613059"},{"key":"e_1_2_9_15_1","first-page":"419","article-title":"Clinical evaluation of recombinant human factor VIII (BAY w 6240) in the treatment of hemophilia A","volume":"54","author":"Fukui H","year":"1991","journal-title":"Int J Hematol"}],"container-title":["Haemophilia"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fhae.13324","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/hae.13324","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,23]],"date-time":"2023-09-23T17:17:17Z","timestamp":1695489437000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/hae.13324"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2017,8,17]]},"references-count":14,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2018,1]]}},"alternative-id":["10.1111\/hae.13324"],"URL":"https:\/\/doi.org\/10.1111\/hae.13324","archive":["Portico"],"relation":{},"ISSN":["1351-8216","1365-2516"],"issn-type":[{"type":"print","value":"1351-8216"},{"type":"electronic","value":"1365-2516"}],"subject":[],"published":{"date-parts":[[2017,8,17]]}}}