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dc.contributor.authorErich V. de Paulaen_US
dc.contributor.authorKaan Kavaklien_US
dc.contributor.authorJohnny Mahlanguen_US
dc.contributor.authorYasmin Ayoben_US
dc.contributor.authorSteven R. Lentzen_US
dc.contributor.authorMassimo Morfinien_US
dc.contributor.authorLászló Nemesen_US
dc.contributor.authorSilva Z. Šaleken_US
dc.contributor.authorMidori Shimaen_US
dc.contributor.authorJerzy Windygaen_US
dc.contributor.authorSilke Ehrenforthen_US
dc.contributor.authorAmpaiwan Chuansumriten_US
dc.contributor.otherUniversidade Estadual de Campinasen_US
dc.contributor.otherEge University Medical Schoolen_US
dc.contributor.otherAcademic Hospitalen_US
dc.contributor.otherNational Blood Centeren_US
dc.contributor.otherUniversity of Iowaen_US
dc.contributor.otherAzienda Ospedaliera Careggien_US
dc.contributor.otherNational Hemophilia Centeren_US
dc.contributor.otherUniversity of Zagreb School of Medicineen_US
dc.contributor.otherNara Kenritsu Ika Daigaku Fozuku Byoinen_US
dc.contributor.otherInstitute of Haematology and Transfusion Medicine, Warsawen_US
dc.contributor.otherNovo Nordisk ASen_US
dc.contributor.otherMahidol Universityen_US
dc.identifier.citationJournal of Thrombosis and Haemostasis. Vol.10, No.1 (2012), 81-89en_US
dc.description.abstractSummary. Background:A recombinant factor VIIa analog (NN1731; vatreptacog alfa [activated]) was developed to provide safe, rapid and sustained resolution of bleeds in patients with hemophilia and inhibitors. Patients/Methods:This global, prospective, randomized, double-blinded, active-controlled, dose-escalation trial evaluated and compared one to three doses of vatreptacog alfa at 5, 10, 20, 40, and 80μgkg -1 with one to three doses of recombinant FVIIa (rFVIIa) at 90μgkg -1 in the treatment of acute joint bleeds in hemophilia patients with inhibitors. The primary endpoint comprised adverse events; secondary endpoints were evaluations of immunogenicity, pharmacokinetics, and efficacy. Results and Conclusions:Overall, 96 joint bleeds in 51 patients ( > 12 years of age) were dosed. Vatreptacog alfa was well tolerated, with a low frequency of adverse events. No immunogenic or thrombotic events related to vatreptacog alfa were reported. A high efficacy rate of vatreptacog alfa in controlling acute joint bleeds was observed; 98% of bleeds were controlled within 9h of the initial dose in a combined evaluation of 20-80μgkg -1 vatreptacog alfa. The efficacy rate observed for rFVIIa (90%) is consistent with data from published clinical trials. The trial was not powered to compare efficacy, and further trials are needed to investigate the efficacy of vatreptacog alfa as compared with that of rFVIIa. The trial was registered at (Registration Number: NCT00486278). © 2011 International Society on Thrombosis and Haemostasis.en_US
dc.rightsMahidol Universityen_US
dc.titleRecombinant factor VIIa analog (vatreptacog alfa [activated]) for treatment of joint bleeds in hemophilia patients with inhibitors: A randomized controlled trialen_US
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