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

PHASE2RecruitingINTERVENTIONAL
Enrollment

256

Participants

Timeline

Start Date

October 11, 2023

Primary Completion Date

November 30, 2028

Study Completion Date

November 30, 2028

Conditions
CirrhosisCirrhosis, LiverCirrhosis EarlyCirrhosis Due to Hepatitis BCirrhosis AdvancedCirrhosis InfectiousCirrhosis AlcoholicCirrhosis Due to Hepatitis C
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.

Trial Locations (13)

10021

RECRUITING

New York Presbyterian/Weill Cornell, New York

10031

RECRUITING

Columbia University Iriving School of Medicine, New York

23298

RECRUITING

Virginia Commonwealth University, Richmond

27710

RECRUITING

Duke Liver Center, Durham

33122

RECRUITING

University of Miami Health System, Miami

44192

RECRUITING

Cleveland Clinic, Cleveland

48109

RECRUITING

University of Michigan, Ann Arbor

55901

RECRUITING

Mayo Clinic, Rochester

90033

RECRUITING

Keck Medical Center of USC, Los Angeles

RECRUITING

LAC + USC Medical Center, Los Angeles

92035

RECRUITING

University of California San Diego NAFLD Research Center, La Jolla

94110

RECRUITING

UCSF/Zuckerberg San Francisco General Hospital and Trauma Center, San Francisco

94143

RECRUITING

UCSF Medical Center, San Francisco

All Listed Sponsors
collaborator

The Cleveland Clinic

OTHER

collaborator

Columbia University

OTHER

collaborator

Weill Medical College of Cornell University

OTHER

collaborator

Duke University

OTHER

collaborator

Mayo Clinic

OTHER

collaborator

University of Miami

OTHER

collaborator

University of Michigan

OTHER

collaborator

University of California, San Diego

OTHER

collaborator

University of California, San Francisco

OTHER

collaborator

LAC+USC Medical Center

OTHER

collaborator

Virginia Commonwealth University

OTHER

collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

collaborator

National Cancer Institute (NCI)

NIH

collaborator

University of Southern California

OTHER

lead

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

NIH