[Clinical testing of Premofil M SRK, a blood coagulation factor VIII concentrate purified from human plasma using...

Premofil M SRK, licensed in Switzerland by the IKS since mid-1990, was clinically tested in close collaboration with 7 hemophilia treatment centers. Up to May 1991, we collected results of in vivo recovery from 17 patients, half-life determinations from 12, and safety data from 9 who were exclusively treated with the preparation for several months. The mean in vivo recovery of factor VIII was calculated to be 77 +/- 14%; the rise in factor VIII activity in plasma following injection of one unit/kg body weight was 1.6 +/- 0.3 units/dl. The mean halflife was 11.9 +/- 4.6 hours. No side reactions were registered throughout the study period. None of the patients showed any signs of HIV or hepatitis infection. It can bei concluded that Premofil M SRK fulfills the requirements related to tolerance, efficacy and safety for a factor VIII concentrate.