Hepatitis C Clinical Trial
Official title:
Chronic Hepatitis C: Treatment of (Peg)Interferon Alpha - Ribavirin Non-Responders With Pegylated Interferon alpha2b, Ribavirin, AdoMet and Betaine
50-60% of patients with chronic hepatitis C are not cured by treatment with pegylated IFNα
plus ribavirin.
Retreatment of non-responders of previous (pegylated) IFNα plus ribavirin therapies with
pegylated IFNα plus ribavirin results in a sustained response in less than 10% of the
patients.
Extensive analysis of IFNα signaling in cells expressing HCV proteins, in transgenic mice
expressing HCV proteins, and in liver biopsies from patients with chronic hepatitis C point
to STAT1 methylation as an important posttranslational modification targeted by HCV to
inhibit IFNα signaling.
STAT1 methylation can be increased and IFNα can be improved by adding AdoMet and betaine.
The study is designed to test the hypothesis that a combination treatment with pegylated
IFNα2b, ribavirin, AdoMet and betaine is superior to the current standard combination
therapy with pegylated IFNα plus ribavirin.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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