{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T00:54:16Z","timestamp":1790729656497,"version":"4.1.0"},"reference-count":20,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2015,5,20]],"date-time":"2015-05-20T00:00:00Z","timestamp":1432080000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100008322","name":"CSL Behring","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100008322","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Haemophilia"],"published-print":{"date-parts":[[2015,11]]},"abstract":"<jats:sec><jats:title>Introduction<\/jats:title><jats:p>rIX\u2010FP is a coagulation factor IX (recombinant), albumin fusion protein with more than fivefold half\u2010life prolongation over other standard factor IX (FIX) products available on the market.<\/jats:p><\/jats:sec><jats:sec><jats:title>Aim<\/jats:title><jats:p>This prospective phase II, open\u2010label study evaluated the safety and efficacy of rIX\u2010FP for the prevention of bleeding episodes during weekly prophylaxis and assessed the haemostatic efficacy for on\u2010demand treatment of bleeding episodes in previously treated patients with haemophilia B.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>The study consisted of a 10\u201314\u00a0day evaluation of rIX\u2010FP pharmacokinetics (PK), and an 11\u00a0month safety and efficacy evaluation period with subjects receiving weekly prophylaxis treatment. Safety was evaluated by the occurrence of related adverse events, and immunogenic events, including development of inhibitors. Efficacy was evaluated by annualized spontaneous bleeding rate (AsBR), and the number of injections to achieve haemostasis.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Seventeen subjects participated in the study, 13 received weekly prophylaxis and 4 received episodic treatment only. No inhibitors were detected in any subject. The mean and median AsBR were 1.25, and 1.13 respectively in the weekly prophylaxis arm. All bleeding episodes were treated with 1 or 2 injections of rIX\u2010FP. Three prophylaxis subjects who were treated on demand prior to study entry had &gt;85% reduction in AsBR compared to the bleeding rate prior to study entry.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>This study demonstrated the efficacy for weekly routine prophylaxis of rIX\u2010FP to prevent spontaneous bleeding episodes and for the treatment of bleeding episodes. In addition no safety issues were detected during the study and an improved PK profile was demonstrated.<\/jats:p><\/jats:sec>","DOI":"10.1111\/hae.12721","type":"journal-article","created":{"date-parts":[[2015,5,20]],"date-time":"2015-05-20T07:42:25Z","timestamp":1432107745000},"page":"784-790","source":"Crossref","is-referenced-by-count":37,"title":["Results of a phase I\/II open\u2010label, safety and efficacy trial of coagulation factor IX (recombinant), albumin fusion protein in haemophilia B patients"],"prefix":"10.1111","volume":"21","author":[{"given":"U.","family":"Martinowitz","sequence":"first","affiliation":[{"name":"The Israeli National Hemophilia Center Chaim Sheba Medical Center Tel Hashomer Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"T.","family":"Lissitchkov","sequence":"additional","affiliation":[{"name":"Department of Coagulation Disorders and Anemia SHAT Joan Pavel Sofia Bulgaria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.","family":"Lubetsky","sequence":"additional","affiliation":[{"name":"The Israeli National Hemophilia Center Chaim Sheba Medical Center Tel Hashomer Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"G.","family":"Jotov","sequence":"additional","affiliation":[{"name":"Department of Coagulation Disorders and Anemia SHAT Joan Pavel Sofia Bulgaria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"T.","family":"Barazani\u2010Brutman","sequence":"additional","affiliation":[{"name":"The Israeli National Hemophilia Center Chaim Sheba Medical Center Tel Hashomer Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C.","family":"Voigt","sequence":"additional","affiliation":[{"name":"CRD CSL Behring King of Prussia PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"I.","family":"Jacobs","sequence":"additional","affiliation":[{"name":"CRD CSL Behring King of Prussia PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"T.","family":"Wuerfel","sequence":"additional","affiliation":[{"name":"PRD CSL Behring GmbH Marburg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"E.","family":"Santagostino","sequence":"additional","affiliation":[{"name":"Maggiore Hospital Policlinico IRCCS C\u00e0 Granda Foundation Milano Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2015,5,20]]},"reference":[{"key":"e_1_2_8_2_1","unstructured":"National Hemophilia Foundation.MASAC recommendation #179: concerning prophylaxis (regular administration of clotting factor concentrate to prevent bleeding).2007. Available athttp:\/\/www.hemophilia.org\/NHFWeb\/MainPgs\/MainNHF.aspx?menuid=57&contentid=1007. 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EMEA 2009CHMP\/BPWP\/144552\/2009. Available athttp:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Scientific_guideline\/2009\/09\/WC500003634.pdf. Accessed February 25 2015."},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.1055\/s-0038-1653759"},{"key":"e_1_2_8_20_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0049-3848(13)70152-X"},{"key":"e_1_2_8_21_1","unstructured":"Benefix Package Insert.2011. Available athttp:\/\/labeling.pfizer.com\/showlabeling.aspx?id=492. 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