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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Recombinant factor VIIa analog (vatreptacog alfa [activated]) for treatment of joint bleeds in hemophilia patients with inhibitors: A randomized controlled trial
Journal of Thrombosis and Haemostasis, Volume 10, No. 1, Year 2012
Notification
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Description
Summary. 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 ClinicalTrials.gov (Registration Number: NCT00486278). © 2011 International Society on Thrombosis and Haemostasis.
Authors & Co-Authors
De Paula, Erich V.
Brazil, Campinas
Universidade Estadual de Campinas
Kavaklı, Kaan R.
Turkey, Izmir
Ege University Medical School
Mahlangu, Johnny Ndoni
South Africa, Johannesburg
Charlotte Maxeke Johannesburg Academic Hospital
Ayob, Yasmin
Malaysia, Kuala Lumpur
National Blood Center
Lentz, Steven R.
United States, Iowa City
University of Iowa
Morfini, Massimo
Italy, Florence
Azienda Ospedaliera Careggi
Nemes, Laśzló
Hungary, Budapest
National Hemophilia Center
Župančić-Šalek, Silva
Croatia, Zagreb
Kbc Zagreb
Shima, Midori
Japan, Kashihara
Nara Medical University Hospital
Windyga, Jerzy
Poland, Warsaw
Institute of Haematology and Transfusion Medicine, Warsaw
Ehrenforth, Silke
Denmark, Bagsvard
Novo Nordisk A/s
Chuansumrit, Ampaiwan
Thailand, Bangkok
Ramathibodi Hospital
Statistics
Citations: 33
Authors: 12
Affiliations: 12
Identifiers
Doi:
10.1111/j.1538-7836.2011.04549.x
ISSN:
15387933
e-ISSN:
15387836
Study Design
Cohort Study
Study Approach
Quantitative