CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 60 target
Drug / intervention
Atorvastatin 20mg +1 moredrug
Likely dose
Atorvastatin 20mgfrom record
Key inclusion· 7
  • ✓Male or female age > 18 years
  • ✓Clinically or histologically diagnosed advanced liver fibrosis or cirrhosis
  • ✓High-risk for HCC per FIB-4 index at screening
  • ✓PLSec score ≥ 3 in screening blood samples
Key exclusion· 14
  • ✕Alpha-1-antitrypsin deficiency, Wilson disease, hemochromatosis, iron overload, or drug-induced liver injury (unless overlapping with SLD)
  • ✕PBC, PSC, or AIH unless overlapping with steatotic liver disease
  • ✕Clinically significant illness or major medical disorder interfering with treatment or compliance
  • ✕Known HIV infection

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05028829
NCT05028829Phase 2RecruitingOn TrackUpdated 9mo ago
Long Recruiting
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Multi-center Double Blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Long-term Atorvastatin (20 mg/Day) v. Placebo on HCC Risk in Individuals With Advanced Liver Fibrosis

Raymond Chung·interventional·Posted Aug 31, 2021·Updated Sep 23, 2025

In Brief

A Phase 2 clinical trial evaluating Atorvastatin 20mg and Placebo for Liver Fibroses and Cirrhosis. Currently recruiting, targeting 60 participants across 2 sites.

Detailed Summary

Prospective randomized, multi-center, double blind placebo-controlled trial to assess the chemopreventive impact of atorvastatin (20 mg oral) vs placebo in up to 60 adults with advanced fibrosis at high risk of developing HCC.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLiver Fibroses, Cirrhosis
CountriesUnited States
CollaboratorsUniversity of Texas Southwestern Medical Center

Timeline

Phase 2Recruiting
2022202320242025202620272028202920302031
First PostedAug 31, 2021
Enrollment StartMay 10, 2023
Primary CompletionDec 31, 2026
Study CompletionMar 1, 2031
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 4.8 years agoPrimary completion in 6 months

Interventions

Atorvastatin 20mgdrug

Oral administration of atorvastatin 20 mg

Placebodrug

Oral administration of placebo