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A phase I single-arm, multicenter pilot study aimed at validating γ-OHPdG as a biomarker and testing the effects of Polyphenon E® on its levels in patients with cirrhosis

Trial Summary

This is a single arm, multicenter phase I study of subjects with cirrhotic livers expressing high levels (score 3 and above) of gamma-hydroxypropanodeoxyguanosine (γ-OHPdG) in their baseline biopsy, who will receive Polyphenon E® for 24 weeks. This study is a dose escalation design. Participants in each cohort will be monitored for 4 weeks for Discontinue Therapy Criteria (DTC) before additional participants will be enrolled for the next dose cohort.