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Haemophilia ; 17(5): e963-8, 2011 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-21682818

RESUMEN

N8, a new recombinant factor VIII (rFVIII) compound developed for the treatment of haemophilia A, is produced in Chinese hamster ovary (CHO) cells and formulated without human- or animal-derived materials. The aim of the present study was to compare the pharmacokinetics (PK) and the procoagulant effect, measured by ex vivo whole blood clot formation, of N8 and a commercial rFVIII in a cross-over study in haemophilia A dogs. N8 and Advate® (100 IU kg⁻¹) were administered intravenously to three haemophilia A dogs. Blood was sampled between 0 and 120 h postdose and FVIII:C analysed. PK parameters maximum plasma concentration, area under the curve, half-life (t(½)), clearance, mean residence time (MRT) and volume of distribution and incremental recovery were calculated. Whole blood clotting time (WBCT) and thromboelastography (TEG®) were used to determine the haemostatic potential. No adverse reactions were observed with N8 or Advate ®. N8 and Advate® exhibited similar PK parameters, with t(½) 7.7-11 h and MRT 11-14 h. Both rFVIII compounds corrected the prolonged WBCT (> 48 min) to the range of normal dogs (8-12 min), i.e. N8 to 7.5-10.5 min and Advate® to 7.5-11.5 min. N8 and Advate® also normalized the whole blood clot formation according to TEG®. The native whole blood clotting assays (WBCT, TEG®) appeared to be more sensitive to low concentrations of FVIII than assays in citrated plasma samples. In conclusion, comparison of N8 and Advate ® in haemophilia A dogs revealed similar safety, similar PK and similar effects in whole blood clot formation assays.


Asunto(s)
Coagulación Sanguínea/efectos de los fármacos , Factor VIII/farmacocinética , Hemofilia A/sangre , Proteínas Recombinantes/farmacocinética , Animales , Estudios Cruzados , Enfermedades de los Perros/sangre , Enfermedades de los Perros/tratamiento farmacológico , Perros , Evaluación Preclínica de Medicamentos/métodos , Femenino , Semivida , Hemofilia A/tratamiento farmacológico , Hemofilia A/inmunología , Hemofilia A/veterinaria , Hemostasis/efectos de los fármacos , Inyecciones Intravenosas , Masculino , Tasa de Depuración Metabólica
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