RecruitingPhase 2NCT06015022
EGCG for Hepatocellular Carcinoma Chemoprevention
Phase II Randomized Controlled Trial of Epigallocatechin Gallate for Hepatocellular Carcinoma Chemoprevention
Sponsor
University of Texas Southwestern Medical Center
Enrollment
60 participants
Start Date
Sep 1, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
This phase II trial tests epigallocatechin gallate (EGCG) for its efficacy and safety in preventing development of hepatocellular carcinoma (HCC) in patients with liver cirrhosis.
Eligibility
Min Age: 18 Years
Inclusion Criteria10
- Adults (≥ 18 years-old)
- Clinically and/or histologically diagnosed cirrhosis
- No active hepatic decompensation
- No prior history of HCC
- Adequate hematologic, hepatic, and renal function
- Karnofsky performance status score ≥70
- Both sexes and all racial/ethnic groups will be considered
- FIB-4 index \> 3.25
- High-risk PLSec at baseline
- Absence of HLA-B\*35:01
Exclusion Criteria6
- Prior or ongoing use of EGCG
- History of adverse reaction to green tea products
- Severe obesity (BMI \> 40 kg/m2)
- Active drinking
- EGCG treatment \<4 weeks or \<80% of planned regimen at the end of week 4
- HCC development during the study
Interventions
DRUGEpigallocatechin gallate (EGCG)
EGCG is a green tea-derived catechin
OTHERPlacebo
Placebo in the same capsule with the experimental agent (EGCG).
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06015022
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