Clinical safety of recombinant factor VIII. The rFactor VIII Clinical Trial Group.

The safety of rFVIII has been studied in patients with severe or moderate hemophilia A in a noncontrolled observation study. A total of 40 patients participated in the study. Thirteen patients were included in stage I and 40 patients in stage II. Patients were treated at 11 centers in North America and Europe. As the results show, rFVIII is a substance with only a few unspecific side effects. Because of the constantly investigated infusion, vital signs and laboratory tests like hematology tests, serum chemistries, and urinalyses an elevation of the transaminases was found in 3 patients, which would not be correlated to rFVIII, as these patients had had in the past hepatitis B and probably non-A non-B hepatitis. Further studies with more patients will show whether these results can be confirmed.