Safety and Efficacy of Atorvastatin v. Placebo on HCC Risk — TORCH  

Cirrhosis Clinical Trial

Official title: 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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

The study objective is to investigate the chemopreventive efficacy of atorvastatin (20 mg) on HCC risk compared to placebo in adults with advanced fibrosis (i.e. METAVIR fibrosis stage 3-4) and high-risk PLSec (defined by pre-randomization blood-based assay). HCC risk will be measured by changes in prognostic liver secretome signature (PLSec) risk score after oral administration of atorvastatin for 1 year with up to 5 years post-treatment of chart monitoring. ;

Related Conditions & MeSH terms

• Cirrhosis
• Fibrosis
• Liver Cirrhosis
• Liver Fibroses

• NCT number: NCT05028829
• Study type: Interventional
• Source: Massachusetts General Hospital
• Contact: Raymond Chung, MD
• Phone: 617-724-7526
• Email: chung.raymond@mgh.harvard.edu
• Status: Recruiting
• Phase: Phase 2
• Start date: May 10, 2023
• Completion date: March 1, 2031