RecruitingPhase 2NCT05832229

Liver Cirrhosis Network Rosuvastatin Efficacy and Safety for Cirrhosis in the United States

Liver Cirrhosis Network (LCN) Rosuvastatin Efficacy and Safety for Cirrhosis in the United States (RESCU): A Double-Blind Randomized, Placebo-Controlled Phase 2 Study


Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Enrollment

256 participants

Start Date

Dec 7, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a double-blind, phase 2 study to evaluate safety and efficacy of rosuvastatin in comparison to placebo after 2 years in patients with compensated cirrhosis.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether rosuvastatin (a common cholesterol-lowering medication) can slow liver disease progression in people with cirrhosis (advanced liver scarring) caused by fatty liver disease, alcohol-related liver disease, or treated hepatitis B or C. The goal is to see if this affordable medication can reduce liver stiffness and prevent serious complications. **You may be eligible if...** - You are between 18 and 75 years old - You have liver cirrhosis confirmed by biopsy or imaging/lab tests - Your cirrhosis is "compensated" — meaning you have not recently had fluid buildup, confusion (from liver failure), or bleeding from enlarged veins - Your liver stiffness on a special scan (elastography) is 15 kPa or higher **You may NOT be eligible if...** - You have had recent complications such as fluid buildup in the abdomen, episodes of confusion, or bleeding from your esophagus - You are on diuretics (water pills) for liver-related fluid retention - You have decompensated liver disease (liver is failing) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRosuvastatin

Patients meeting all eligibility criteria will be assigned to a randomization arm prior to initiation of a 4-week lead-in phase of the study. All participants will undergo a 4-week, open-label active run-in phase to evaluate initial safety and adherence to rosuvastatin. During this active run-phase, all participants will receive target dose rosuvastatin-- 20 mg daily (10 mg daily for participants of East-Asian ancestry or on a protease inhibitor). After the active run-in phase, all participants will continue with their pre-assigned randomization (1:1) treatment of rosuvastatin 20 mg daily (10 mg daily for participants of East-Asian ancestry or on a protease inhibitor) or matching placebo.


Locations(13)

University of California San Diego NAFLD Research Center

La Jolla, California, United States

Keck Medical Center of USC

Los Angeles, California, United States

LAC + USC Medical Center

Los Angeles, California, United States

UCSF/Zuckerberg San Francisco General Hospital and Trauma Center

San Francisco, California, United States

UCSF Medical Center

San Francisco, California, United States

University of Miami Health System

Miami, Florida, United States

University of Michigan

Ann Arbor, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

New York Presbyterian/Weill Cornell

New York, New York, United States

Columbia University Iriving School of Medicine

New York, New York, United States

Duke Liver Center

Durham, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

Virginia Commonwealth University

Richmond, Virginia, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05832229


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