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N9\u2010GP<\/jats:styled-content> was administered once\u2010weekly as 10 IU<\/jats:styled-content> kg\u22121<\/jats:sup> or 40 IU<\/jats:styled-content> kg\u22121<\/jats:sup> in adolescents\/adults and 40 IU<\/jats:styled-content> kg\u22121<\/jats:sup> in children. Blood was sampled up to 168 h (1 week) post dose. Standard PK<\/jats:styled-content> was estimated on the basis of plasma FIX<\/jats:styled-content> activity vs. time (PK<\/jats:styled-content> profiles) using non\u2010compartmental methods. Furthermore, a population PK<\/jats:styled-content> analysis and FIX<\/jats:styled-content> activity predictions were performed.<\/jats:p><\/jats:sec>Results<\/jats:title>Incremental recoveries were 0.02 (IU mL<\/jats:styled-content>\u22121<\/jats:sup>)\/(IU<\/jats:styled-content> kg\u22121<\/jats:sup>) in both adolescents\/adults and children. The extended half\u2010life resulted in mean trough levels of 0.27 IU mL<\/jats:styled-content>\u22121<\/jats:sup> for adolescents\/adults and 0.17 IU mL<\/jats:styled-content>\u22121<\/jats:sup> for children at steady\u2010state after weekly dosing at 40 IU<\/jats:styled-content> kg\u22121<\/jats:sup>. The population PK<\/jats:styled-content> analysis confirmed a mono\u2010exponential decay in FIX<\/jats:styled-content> activity and allowed for predictions of FIX<\/jats:styled-content> activity for adolescents\/adults above 0.15 IU mL<\/jats:styled-content>\u22121<\/jats:sup> at all times and 6.4 days week\u22121<\/jats:sup> in children.<\/jats:p><\/jats:sec>Conclusion<\/jats:title>N9\u2010GP<\/jats:styled-content> has the potential to shift previously treated haemophilia B patients from a severe\/moderate disease state into a mild\u2010 or non\u2010haemophilic range for most of the dosing interval, which is expected to reduce the number of bleeding episodes.<\/jats:p><\/jats:sec>","DOI":"10.1111\/hae.13191","type":"journal-article","created":{"date-parts":[[2017,2,24]],"date-time":"2017-02-24T08:49:03Z","timestamp":1487926143000},"page":"547-555","source":"Crossref","is-referenced-by-count":24,"title":["Pharmacokinetics of a novel extended half\u2010life glycoPEG<\/scp>ylated factor IX<\/scp>, nonacog beta pegol (N9\u2010GP<\/scp>) in previously treated patients with haemophilia B: results from two phase 3 clinical trials"],"prefix":"10.1111","volume":"23","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3600-8536","authenticated-orcid":false,"given":"A.","family":"Tiede","sequence":"first","affiliation":[{"name":"Clinic for Haematology, Haemostaseology, Oncology and Stem Cell Transplantation Hannover Medical School Hannover Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"F.","family":"Abdul\u2010Karim","sequence":"additional","affiliation":[{"name":"Hemophilia Clinic National Blood Centre Wilayah Persekutuan Kuala Lumpur Malaysia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5350-1763","authenticated-orcid":false,"given":"M.","family":"Carcao","sequence":"additional","affiliation":[{"name":"Division of Haematology\/Oncology Department of Paediatrics Child Health Evaluative Sciences Research Institute The Hospital for Sick Children University of Toronto Toronto ON Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"P.","family":"Persson","sequence":"additional","affiliation":[{"name":"Novo Nordisk A\/S S\u00f8borg Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"W. 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