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.
Age 18-75 years
Cirrhosis due to nonalcoholic steatohepatitis, alcohol-associated liver disease, or chronic viral hepatitis (treated hepatitis B virus or hepatitis C virus)
At least one liver biopsy within 5 years prior to consent showing either: Metavir stage 4 fibrosis; Ishak Stage 5-6 fibrosis, OR
The first measure must be ≥ 15 kilopascal.
Currently on a statin or any statin exposure within 24 weeks prior to consent.
Prior peripheral vascular, cardiovascular or cerebrovascular event for which statins are indicated for secondary prevention, OR
Documented familial hypercholesterolemia, heterozygous familial hypercholesterolemia, OR
Fasting LDL-C ≥ 190 mg/dL
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Lead sponsor
The Cleveland Clinic
Collaborator
Columbia University
Collaborator
Weill Medical College of Cornell University
Collaborator
Duke University
Collaborator
Mayo Clinic
Collaborator
University of Miami
Collaborator
University of Michigan
Collaborator
University of California, San Diego
Collaborator
University of California, San Francisco
Collaborator
LAC+USC Medical Center
Collaborator
Virginia Commonwealth University
Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
National Cancer Institute (NCI)
Collaborator
University of Southern California
Collaborator