Clinical evaluation of the hepatitis safety of a beta-propiolactone/ultraviolet treated factor IX concentrate (PPSB).

The association of viral hepatitis, type B, with the use of prothrombin complex concentrates (PPSB) has been well documented. PPSB prepared from cold-sterilized plasma (beta-propiolactone treated and UV irradiated) has been shown not to induce hepatitis in chimpanzees. 500 U of cold-sterilized PPSB were infused into 5 healthy male volunteers. Previous to, and up to 6 months after, PPSB-application in addition to careful clinical investigations, the following hepatitis parameters were determined: SGOT, SGPT, y-GT, alkaline phosphatase, total serum bilirubin, HBsAg, HBcAb and HBsAb. On the basis of all of the above parameters there was no indication of induction of viral hepatitis following the application of PPSB prepared from beta-propiolactone/UV treated plasma.