Hepatitis C Clinical Trial
Official title:
Safety and Efficacy of Sustained Interferon Alfa 2b (INF) Therapy of Relapsing Hepatitis C (HCV) Patients Using InfraDure Biopump
Patients who completed the conventional treatment against HCV and relapsed (the virus appeared again in their blood) have no effective therapy.
The rational behind the proposed study is that most patients can not tolerate the prolonged
IFN injections because the side effects. The new proposed treatments allows continous low
doses of IFN to be secreted by the patients himself using his own skin in which the dermo
fibroblasts are enriched by a human gene of erythropoietin. The "biopump" continues to
secret the IFN for several months avoiding the spikes of IFN in the plasma which are
beleived to cause the undesired effects.
Patients will be able to complete a long treatment with low IFN dose and Ribavirin hoping to
induce prolonged remission and cure
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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