Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05832229
PHASE2

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

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

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

256

Start Date

2023-12-07

Completion Date

2029-08-31

Last Updated

2026-01-13

Healthy Volunteers

No

Interventions

DRUG

Rosuvastatin

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