Abstract
Surveillance study was performed in 24 (severe 10, moderate 6, and mild 8) previously untreated patients with hemophilia A to evaluate the safety and efficacy of plasma- derived factor VIII (CROSS EIGHT M, Japanese Red Cross) which has been widely used in Japan. In a total of 534 bleeding episodes during the study, 226 and 138 were judged to be “excellent” and “good”in hemostatic efficacy, respectively. The overall efficacy rate including more than “good” reached 96.4% without any “none” or “worse” cases. One severe patient transiently developed 0.9 BU/ml of inhibitor to factor VIII. Another severe patient developed transient anti-mouse IgG antibody did not show clinical symptoms. Regarding virus transmission, no HBV, HCV or HIV infection was reported, but human parvovirus B19 transmission through this product can not be excluded. The manufacturer has been improving the safety measures against this virus using a screening test by receptor-mediated hemagglutination (RHA) and introduction of nanofiltration during the manufacturing. These results indicate that CROSS EIGHT M has high ability in hemostatic efficacy and low activity in adverse reaction and inhibitor formation.
