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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

The Schema is a timeline of the study. It indicates start/end points, visits expected, major testing to be done, and any other information that is crucial to understanding how the study was completed.



For the Pre-Screen Chart Review, Medical Charts are reviewed by a pathologist for eligibility. Next, for Screen 1: Eligibility, Participants with a diagnosis of liver cirrhosis are seen in clinic: The following is collected, Informed consent, history/physical/conmed review, CT or MRI, FibroScan®, clinical labs, Child Pugh score, pregnancy test, questionnaires, eligibility review. For Screen 2: Liver Biopsy and Eligibility, Participants meeting Screen 1 eligibility criteria are seen in clinic: and, Liver biopsy obtained, samples tested for γ-OHPdG level, slides reviewed and scored by a pathologist. For Study Visit 1: Week 1 Day 1, Participants with high levels of γ-OHPdG (IHC ≥3) meeting eligibility criteria receive Polyphenon E according to the dose escalation schema 3+3 design plus expansion cohort to 24 for Maximum Tolerated Dose: The sequence is, 400 mg EGCG QD, 400 mg EGCG BID, 600 mg EGCG BID, 800 mg EGCG BID, and 1000 mg EGCG BID. Other activities were, Physical, conmed/AE review, clinical labs, dispense agent, urine/blood collection for PK. Weekly or bi-weekly (depending on assigned dose, clinical stability, and liver biochemical stability of the participant) liver function tests. Study Visit 2: Week 13 ± 3 Days, Mid-study clinic visit: Physical, conmed/AE review, clinical labs, dispense agent. Weekly or bi-weekly (depending on assigned dose, clinical stability, and liver biochemical stability of the participant) liver function tests. Study Visit 3: Week 25 ± 3 Days, Last day of agent: Physical exam, conmen/AE review, clinical labs, Child Pugh score, CT or MRI, FibroScan, liver biopsy testing for γ-OHPdG. Study Visit 4: Week 28 ± 3 Days, Follow-up: Physical exam, clinical labs. Primary Objectives: To establish maximum tolerated dose (MTD) and to collect safety data of Polyphenon E/EGCG treatment in patients with cirrhosis. To determine the effects of Polyphenon E/EGCG treatment on the suppression of γ-hydroxy-1,N(2)-propanodeoxyguanosine (γ-OHPdG) levels in cirrhotic liver. Secondary Objectives: To collect Polyphenon E/EGCG pharmacokinetic data in patients with cirrhosis. To determine the effects of Polyphenon E/EGCG treatment on the suppression of γ-hydroxy-1,N(2)-propanodeoxyguanosine (γ-OHPdG) levels in cirrhotic liver by LC-MS assay from baseline to post-treatment. To estimate the fraction of patients with liver cirrhosis that have high levels of γ-OHPdG. Exploratory Objective: To assess the effects of Polyphenon E/EGCG on the grade of cirrhosis as measured by FibroScan and FIB-4 score. To develop an LC-MS and/or ELISA-based method for detecting urinary and blood γ-OHPdG, to correlate with liver ɣ-OHPdG levels. To evaluate any HCC development during the treatment.