[Clinical evaluation of factors VIII and IX manufactured in Hungary, based on results of the first half year].
The development of anti-factor VIII/IX antibodies (inhibitor-induction) and the transmission of viral infections are the most significant complications of haemophilia treatment. The Humafactor-8 and Humafactor-9 are high-purity pasteurized factor VIII and IX concentrates, which are produced from pooled plasma of Hungarian donors by ion-exchange chromatography. The clinical study has been accomplished in two steps: first we have demonstrated the biological efficacy of the concentrates in a phase IV trial. After that we followed 13 patients with severe haemophilia for 6 months in respect of virus-safety and inhibitor-induction. According to our results the recently developed domestic FVIII/FIX concentrates display appropriate biological activities and they are safe as blood-borne virus-transmission and immunogenicity are concerned.
Nemes
L
L
Országos Haematologiai és Immunológiai Intézet Budapest.
Ceglédi
A
A
Szabó
G
G
Varga
M
M
Sas
G
G
D005164:Factor IX / Q000627:therapeutic use*; D005169:Factor VIII / Q000627:therapeutic use*; D006467:Hemophilia A / Q000097:blood / Q000188:drug therapy*; D006801:Humans
D005169:Factor VIII; D005164:Factor IX
Hazai elöállítású VIII és IX faktor készítményekkel nyert tapasztalatok a klinikai alkalmazás elsö fél évének eredményei alapján.