Hazai elöállítású VIII és IX faktor készítményekkel nyert tapasztalatok a klinikai alkalmazás elsö fél évének eredményei alapján.

Translated title of the contribution: Clinical evaluation of factors VIII and IX manufactured in Hungary, based on results of the first half year

L. Nemes, A. Ceglédi, G. Szabó, M. Varga, G. Sas

Research output: Contribution to journalArticle

Abstract

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.

Original languageHungarian
Pages (from-to)749-752
Number of pages4
JournalOrvosi hetilap
Volume139
Issue number13
Publication statusPublished - Mar 29 1998

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ASJC Scopus subject areas

  • Medicine(all)

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