Pharmacokinetic properties of recombinant factor VIII compared with a monoclonally purified concentrate (Hemofil M). The Recombinate Study Group.

Author(s): Morfini M, Longo G, Messori A, Lee M, White G, Mannucci P

Affiliation(s): Hematology Department and Hemophilia Center, University of Florence, Italy.

Publication date & source: 1992-10-05, Thromb Haemost., 68(4):433-5.

Publication type: Clinical Trial; Randomized Controlled Trial

A recombinant FVIII preparation, Recombinate, was compared with a high-purity plasma-derived concentrate, Hemofil M, in 47 hemophilia A patients in a cross-over evaluation of pharmacokinetic properties. The recombinant material showed a significantly lower clearance, volume of distribution, and higher in vivo recovery, but a similar half-life to the plasma-based product. In a comparison with reported data from other standard concentrates, the recombinant preparation exhibited potentially better pharmacokinetic properties in that its clearance was slower and its half-life was longer. We conclude that the recombinant DNA method of preparation does not adversely affect the biological and pharmacological characteristics of the factor VIII molecule.