A pharmacokinetic study of an ion-exchange solvent-detergent-treated high-purity factor VIII concentrate. Haemophilia Directors for Scotland and Northern Ireland.

An ion-exchange chromatography purified factor VIII concentrate (Liberate) that had undergone a solvent-detergent viral inactivation treatment was compared with an intermediate-purity concentrate (Z8), which was terminally heated at 80 degrees C for 72 h, in 15 haemophilia A patients in a blinded crossover pharmacokinetic study. Both products achieved a peak level close to that predicted (100 IU/dl for Liberate and 103 IU/dl for Z8) and there were no significant differences in the recoveries achieved nor of any of the other pharmacokinetic parameters. We conclude that the pharmacokinetic properties of factor VIII:C, following solvent-detergent treatment and ion-exchange chromatography, are equivalent to those of the lower purity terminally heat-treated product (Z8), and it is therefore likely to be a clinically efficacious concentrate.

RCT Entities:   Population Interventions Outcomes