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 NAFLD, ALD, or chronic viral hepatitis (treated HBV or HCV)
The first measure must be ≥ 15.0 kPa.
The two measures must be at least 2 hours apart and no more than 60 days apart from one another.
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
Parallel
Rosuvastatin
DrugPatients 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 . After the active run-in phase, all participants will continue with their pre-assigned randomization (1:1) treatment of rosuvastatin 20 mg daily or matching placebo.
Mean change in liver stiffness
Mean change in liver stiffness as measured in kilopascal with Vibration-Controlled Transient Elastography between study entry and week 96. Range: 2 to 75 kilopascal. Higher stiffness indicates increased disease progression
Time to disease progression
Time to disease progression defined as time to development of decompensation event (ascites, hepatic encephalopathy, variceal bleed) or hepatocellular carcinoma. Analyzed as time-to-event; binary if low counts.
All-cause mortality
All-cause mortality: time-to-event, binary if low counts
Time to development of ascites
Ascites: time-to-event, binary if low counts
Time to development of overt hepatic encephalopathy
Time to development of overt hepatic encephalopathy: time-to-event, binary if low counts
Click on the lead sponsor to view all of their trials.
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
