[Clinical testing of Premofil M SRK, a blood coagulation factor VIII concentrate purified from human plasma using monoclonal an antibodies].
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.
Perret
B A
BA
Zentrallaboratorium Blutspendedienst SRK, Bern.
Poorbeik
M
M
Morell
A
A
D000293:Adolescent; D000328:Adult; D002648:Child; D005169:Factor VIII / Q000737:chemistry / Q000493:pharmacokinetics / Q000627:therapeutic use*; D006207:Half-Life; D006467:Hemophilia A / Q000628:therapy*; D006801:Humans
D005169:Factor VIII
Klinische Prüfung von Premofil M SRK, einem mit monoklonalen Antikörpern hochgereinigten Gerinnungsfaktor VIII-Konzentrat aus Humanplasma.