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Clinical evaluation of factors VIIi and IX manufactured in Hungary, based on results of the first half year

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

Orvosi Hetilap 139(13): 749-752

1998

ISSN/ISBN: 0030-6002
PMID: 9578703
Document Number: 484168
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.

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