Study of Simvastatin to Reduce Liver Fibrosis in Adults With Alcohol-Related Advanced Liver Fibrosis

What this Trial Is About

Researchers are evaluating the effectiveness of simvastatin in reducing liver fibrosis in patients who have advanced fibrosis caused by alcohol use. This study is a randomized, double-blind, placebo-controlled trial aimed at understanding whether simvastatin can improve liver condition in people with significant liver damage due to chronic alcohol-related liver disease. Participants will be randomly assigned to receive either simvastatin or a placebo. Those in the treatment group will take a capsule containing four tablets of simvastatin 10 mg total 40 mg every night. The study includes a treatment period of 18 months during which the effects on liver fibrosis will be carefully monitored and compared between groups. During the study, participants will undergo liver biopsies to measure changes in fibrosis using the Ishak fibrosis score. Other assessments will include monitoring for side effects, liver function, and overall health status. The primary outcome is the change in the histological fibrosis score from baseline after 18 months. Safety and compliance will be closely monitored throughout the study period, which may last up to nearly six years including follow-up.

Efficacy of Simvastatin in Alcoholic Liver Fibrosis