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.
Brackman
H H
HH
University of California, Davis.
Egli
J E
JE
Van Loo
B
B
D000328:Adult; D000368:Aged; D000410:Alanine Transaminase / Q000097:blood; D001219:Aspartate Aminotransferases / Q000097:blood; D001831:Body Temperature; D004244:Dizziness / Q000209:etiology; D004341:Drug Evaluation; D005169:Factor VIII / Q000009:adverse effects* / Q000494:pharmacology / Q000627:therapeutic use; D006467:Hemophilia A / Q000097:blood / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D007022:Hypotension / Q000209:etiology; D008111:Liver Function Tests; D008875:Middle Aged; D011993:Recombinant Fusion Proteins / Q000009:adverse effects* / Q000494:pharmacology / Q000627:therapeutic use
D011993:Recombinant Fusion Proteins; D005169:Factor VIII; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase