Peer-reviewed veterinary case report
New recombinant FVIII drug tested for hemophilia A in dogs
By Karpf, D M et al.·Published in Haemophilia : the official journal of the World Federation of Hemophilia·2011·Biopharmaceutical Research Unit·View original on PubMed →
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Original publication title: Pharmacokinetics and ex vivo whole blood clot formation of a new recombinant FVIII (N8) in haemophilia A dogs.
- Species:
- dog
Plain-English summary
Three dogs with hemophilia A were treated with a new medication called N8, which is designed to help their blood clot properly. After receiving the treatment, blood tests showed that N8 worked just as well as a commonly used medication called Advate in correcting their prolonged bleeding times. Both treatments were safe, with no side effects observed. The dogs' blood clotting times improved significantly, bringing them back to normal levels. This study suggests that N8 is a promising option for managing hemophilia A in dogs.
People also search for: dog hemophilia treatment · N8 factor VIII for dogs · Advate for dog bleeding issues
Abstract
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.
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Search related cases →Original publication on PubMed: https://pubmed.ncbi.nlm.nih.gov/21682818/