RECRUITING

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

Conditions

Cirrhosis Cirrhosis, Liver Cirrhosis Early Cirrhosis Due to Hepatitis B Cirrhosis Advanced Cirrhosis Infectious Cirrhosis Alcoholic Cirrhosis, Biliary Cirrhosis Cryptogenic Cirrhosis Due to Hepatitis C Cirrhosis Due to Primary Sclerosing Cholangitis Liver Nonalcoholic Fatty Liver Disease NASH Nonalcoholic steatohepatitis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2023-10-11

Study Completion:2026-11-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05832229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Age 18-75 years 2. Cirrhosis due to nonalcoholic steatohepatitis, alcohol-associated liver disease, or chronic viral hepatitis (treated hepatitis B virus or hepatitis C virus), or cryptogenic cirrhosis 3. Clinical diagnosis of cirrhosis as defined investigator confirmation and the following: 1. At least one liver biopsy within 5 years prior to consent showing either: Metavir stage 4 fibrosis; Ishak Stage 5-6 fibrosis, OR 2. At least 2 of the following: 4. Two measures of vibration-controlled transient elastography: one at screening and one at the randomization study visit, meeting the following criteria: 1. The first measure must be ≥ 12.5 kilopascal. 2. The two measures must be at least 1 day apart and no more than 60 days apart from one another. 3. The mean of two measurements must be ≥ 12.5 kilopascal. 5. Compensated defined by: 1. Absence of ascites/hydrothorax, hepatic encephalopathy or variceal bleeding currently or in the last 48 weeks, as determined clinically by investigator. 2. If prior history of decompensation, must be without current symptoms of decompensation and no longer requiring treatment of complications for the last 48 weeks, including the use of diuretics for the treatment of ascites, and/or rifaximin or lactulose for the treatment of hepatic encephalopathy. Use of non-selective beta blockers will be allowed. 3. Child-Pugh score \<8 6. Provision of written informed consent.	1. Currently on a statin or any statin exposure within 48 weeks prior to consent. 2. Known indication for statin therapy, defined as: 1. Prior peripheral vascular, cardiovascular or cerebrovascular event for which statins are indicated for secondary prevention, OR 2. Documented familial hypercholesterolemia, heterozygous familial hypercholesterolemia, OR 3. Fasting LDL-C ≥ 190 mg/dL 4. Myocardial infarction, Unstable angina, transient ischemic events, or stroke within 24 weeks of screening. 3. Alcohol Use Disorder Identification Test (AUDIT) score of ≥8. 4. Patients with limitations in attending study visits. 5. Prisoners. 6. Known prior or current hepatocellular carcinoma (HCC) or cholangiocarcinoma. 7. Known transjugular intrahepatic portosystemic shunt (TIPS), balloon retrograde transvenous obliteration (BRTO) or porto-systemic shunt surgery regardless of time of occurrence. 8. Current (in past 24 weeks prior to consenting) use of medications known to cause hepatic fibrogenesis or confound endpoint assessment, defined as: 1. amiodarone 2. methotrexate 3. warfarin 9. Current (in past 24 weeks prior to consenting) use of medications which may increase risk for rosuvastatin-related myositis or drug-induced liver injury, defined as: 15. Known current medical or psychiatric conditions which, in the opinion of the investigator, would make the participant unsuitable for the study for safety reasons or interfere with or prevent adherence to the protocol. 16. The following laboratory abnormalities within 90 days of screening: 1. Absolute neutrophil count \<1.0 x 109 / L 2. Hemoglobin \<10 g/dL 3. Albumin \<3.0 g/dL 4. Prolonged international normalized ratio (INR) \>1.5 5. Total bilirubin ≥ 2.0 mg/dl (unless due to Gilbert's syndrome or hemolysis as denoted by normal direct bilirubin fraction) 6. Uncontrolled diabetes (HbA1c ≥ 9.0%) within past 24 weeks 17. Kidney function abnormalities including: 1. Hepatitis C virus eligible for enrollment if hepatitis C virus RNA negative and after sustained virologic response at 24 weeks 2. Hepatitis B virus eligible if Hepatitis B virus DNA \<100 IU/mL and on treatment 20. Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 200 U/L within the past 24 weeks 21. Documented history of intolerance to statins 22. Serious co-morbid medical disease which in the investigator's opinion renders a life-expectancy less than 96 weeks 23. Active illicit substance abuse, including inhaled or injected drugs, in the 48 weeks prior to screening 24. Pregnancy, planned pregnancy or breast-feeding 25. Current participation in active medication treatment trials (within 24 weeks prior to randomization) or planned participation in active medication treatment trials simultaneous to participation in present trial. 26. Significant existing muscle pain or tenderness as determined by a site physician. 27. Failure or inability to provide informed consent.

Inclusion Criteria

Exclusion Criteria

1. Age 18-75 years
2. Cirrhosis due to nonalcoholic steatohepatitis, alcohol-associated liver disease, or chronic viral hepatitis (treated hepatitis B virus or hepatitis C virus), or cryptogenic cirrhosis
3. Clinical diagnosis of cirrhosis as defined investigator confirmation and the following:
1. At least one liver biopsy within 5 years prior to consent showing either: Metavir stage 4 fibrosis; Ishak Stage 5-6 fibrosis, OR
2. At least 2 of the following:
4. Two measures of vibration-controlled transient elastography: one at screening and one at the randomization study visit, meeting the following criteria:
1. The first measure must be ≥ 12.5 kilopascal.
2. The two measures must be at least 1 day apart and no more than 60 days apart from one another.
3. The mean of two measurements must be ≥ 12.5 kilopascal.
5. Compensated defined by:
1. Absence of ascites/hydrothorax, hepatic encephalopathy or variceal bleeding currently or in the last 48 weeks, as determined clinically by investigator.
2. If prior history of decompensation, must be without current symptoms of decompensation and no longer requiring treatment of complications for the last 48 weeks, including the use of diuretics for the treatment of ascites, and/or rifaximin or lactulose for the treatment of hepatic encephalopathy. Use of non-selective beta blockers will be allowed.
3. Child-Pugh score \<8
6. Provision of written informed consent.

1. Currently on a statin or any statin exposure within 48 weeks prior to consent.
2. Known indication for statin therapy, defined as:
1. Prior peripheral vascular, cardiovascular or cerebrovascular event for which statins are indicated for secondary prevention, OR
2. Documented familial hypercholesterolemia, heterozygous familial hypercholesterolemia, OR
3. Fasting LDL-C ≥ 190 mg/dL
4. Myocardial infarction, Unstable angina, transient ischemic events, or stroke within 24 weeks of screening.
3. Alcohol Use Disorder Identification Test (AUDIT) score of ≥8. 4. Patients with limitations in attending study visits. 5. Prisoners. 6. Known prior or current hepatocellular carcinoma (HCC) or cholangiocarcinoma. 7. Known transjugular intrahepatic portosystemic shunt (TIPS), balloon retrograde transvenous obliteration (BRTO) or porto-systemic shunt surgery regardless of time of occurrence.
8. Current (in past 24 weeks prior to consenting) use of medications known to cause hepatic fibrogenesis or confound endpoint assessment, defined as:
1. amiodarone
2. methotrexate
3. warfarin 9. Current (in past 24 weeks prior to consenting) use of medications which may increase risk for rosuvastatin-related myositis or drug-induced liver injury, defined as:
15. Known current medical or psychiatric conditions which, in the opinion of the investigator, would make the participant unsuitable for the study for safety reasons or interfere with or prevent adherence to the protocol.
16. The following laboratory abnormalities within 90 days of screening:
1. Absolute neutrophil count \<1.0 x 109 / L
2. Hemoglobin \<10 g/dL
3. Albumin \<3.0 g/dL
4. Prolonged international normalized ratio (INR) \>1.5
5. Total bilirubin ≥ 2.0 mg/dl (unless due to Gilbert's syndrome or hemolysis as denoted by normal direct bilirubin fraction)
6. Uncontrolled diabetes (HbA1c ≥ 9.0%) within past 24 weeks 17. Kidney function abnormalities including:
1. Hepatitis C virus eligible for enrollment if hepatitis C virus RNA negative and after sustained virologic response at 24 weeks
2. Hepatitis B virus eligible if Hepatitis B virus DNA \<100 IU/mL and on treatment 20. Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 200 U/L within the past 24 weeks 21. Documented history of intolerance to statins 22. Serious co-morbid medical disease which in the investigator's opinion renders a life-expectancy less than 96 weeks 23. Active illicit substance abuse, including inhaled or injected drugs, in the 48 weeks prior to screening 24. Pregnancy, planned pregnancy or breast-feeding 25. Current participation in active medication treatment trials (within 24 weeks prior to randomization) or planned participation in active medication treatment trials simultaneous to participation in present trial.
26. Significant existing muscle pain or tenderness as determined by a site physician.
27. Failure or inability to provide informed consent.

Contacts and Locations

Study Contact

Crystal Santillanes

CONTACT

312-503-5536

lcn@northwestern.edu

Mary Beth Tull

CONTACT

312-503-4746

mary.tull@northwestern.edu

Principal Investigator

Jody Ciolino

PRINCIPAL_INVESTIGATOR

Northwestern University

Study Locations (Sites)

University of California San Diego NAFLD Research Center

La Jolla, California, 92035

United States

Keck Medical Center of USC

Los Angeles, California, 90033

United States

LAC + USC Medical Center

Los Angeles, California, 90033

United States

UCSF/Zuckerberg San Francisco General Hospital and Trauma Center

San Francisco, California, 94110

United States

UCSF Medical Center

San Francisco, California, 94143

United States

University of Miami Health System

Miami, Florida, 33122

United States

University of Michigan

Ann Arbor, Michigan, 48109

United States

Mayo Clinic

Rochester, Minnesota, 55901

United States

New York Presbyterian/Weill Cornell

New York, New York, 10021

United States

Columbia University Iriving School of Medicine

New York, New York, 10031

United States

Duke Liver Center

Durham, North Carolina, 27710

United States

Cleveland Clinic

Cleveland, Ohio, 44192

United States

Virginia Commonwealth University

Richmond, Virginia, 23298

United States

Collaborators and Investigators

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

Jody Ciolino, PRINCIPAL_INVESTIGATOR, Northwestern University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-11

Study Completion Date2026-11-01

Study Record Updates

Study Start Date2023-10-11

Study Completion Date2026-11-01

Terms related to this study

Keywords Provided by Researchers

Cirrhosis
Liver
Nonalcoholic Fatty Liver Disease
NASH
Nonalcoholic steatohepatitis

Additional Relevant MeSH Terms

Cirrhosis
Cirrhosis, Liver
Cirrhosis Early
Cirrhosis Due to Hepatitis B
Cirrhosis Advanced
Cirrhosis Infectious
Cirrhosis Alcoholic
Cirrhosis, Biliary
Cirrhosis Cryptogenic
Cirrhosis Due to Hepatitis C
Cirrhosis Due to Primary Sclerosing Cholangitis