Cirrhosis study: Rosuvastatin
Official title Liver Cirrhosis Network Rosuvastatin Efficacy and Safety for Cirrhosis in the United States
ClinicalTrials.gov ID: NCT05832229
What this study is testing
What is Rosuvastatin?
This is an investigational medicine being studied to see if it helps people with a specific type of liver disease called compensated cirrhosis. It is designed to lower the amount of cholesterol in your blood by affecting how your liver makes it.
Also referred to as Rosuvastatin 20 mg.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out if rosuvastatin is safe and effective for people with stable liver cirrhosis.
- Who it's for
- The study is looking for adults with compensated cirrhosis, which means their liver disease is not yet causing severe complications.
- What's involved
- Participants will take either rosuvastatin or a placebo (a pill with no active medicine) and undergo regular health checks to monitor their liver function.
- Time commitment
- The study lasts for 2 years and requires regular visits to the clinic for testing and monitoring.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Age 18-75 years
- Cirrhosis due to NAFLD, ALD, or chronic viral hepatitis (treated HBV or HCV)
- Clinical diagnosis of cirrhosis as defined by investigator confirmation and the following: a.
- 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.
You likely can't join if
- 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
- Myocardial infarction, Unstable angina, transient ischemic events, or stroke within 24 weeks of screening.
- Alcohol Use Disorder Identification Test (AUDIT) total score of ≥8 at screening.
See the full eligibility criteria
- Age 18-75 years
- Cirrhosis due to NAFLD, ALD, or chronic viral hepatitis (treated HBV or HCV)
- Clinical diagnosis of cirrhosis as defined by investigator confirmation and the following: a. At least one liver biopsy within 5 years prior to consent showing either: Metavir stage 4 fibrosis
- 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.
- The mean of two measurements must be ≥ 15.0 kPa.
- Additionally, both screening and open-label dispense liver stiffness measures must be ≤50 kPa
- Absence of ascites/hydrothorax, hepatic encephalopathy or variceal bleeding currently or in the last 48 weeks, as determined clinically by investigator.
- 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...
- Child-Pugh score \<8
- Provision of written informed consent.
- 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
- Myocardial infarction, Unstable angina, transient ischemic events, or stroke within 24 weeks of screening.
- Alcohol Use Disorder Identification Test (AUDIT) total score of ≥8 at screening.
- Patients with limitations in attending study visits.
- Prisoners.
- Known prior or current hepatocellular carcinoma (HCC) or cholangiocarcinoma.
- Known transjugular intrahepatic portosystemic shunt (TIPS), balloon retrograde transvenous obliteration (BRTO) or porto-systemic shunt surgery regardless of time of occurrence.
- amiodarone
- methotrexate
- warfarin
- fenofibrate
- erythromycin
- gemfibrozil
- niacin (500 mg or more)
- HIV protease inhibitors (darunivar, indinavir, nelfinavir, amprenavir)
- colchicine
- cyclosporin
- Additional medications that will be excluded: atazanavir/ritonavir capmatinib darolutamide dasabuvir/ombitasvir/paritaprevir/ritonavir ledipasvir/sofosbuvir elbasvir/grazoprevir erythromycin lopinavir/ritonavir...
- Presence of portal or hepatic vein thrombosis
- Diagnosis of untreated hypothyroidism or on unstable treatment regimen for hypothyroidism
- Receiving an elemental diet or parenteral nutrition
- Chronic pancreatitis or pancreatic insufficiency
- Etiology of cirrhosis other than ALD, NAFLD, or viral hepatitis (excluded diagnoses include cryptogenic immune-mediated such as AIH, PSC and PBC, cardiac cirrhosis or Fontan-associated liver disease, A1AT, Wilson's...
- Conditions which may confound study outcome: a. Unstable or active inflammatory bowel disease b. Active infection c.
- 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.
- The following laboratory abnormalities within 90 days of screening: a. Hemoglobin \ 1.5 d. Total bilirubin ≥ 2.0 mg/dl (unless due to Gilbert's syndrome or hemolysis as denoted by normal direct bilirubin fraction) e.
- Dialysis
- Baseline eGFR \< 30 cc/min with CKD-Epi equation
- Known nephrotic proteinuria, defined as 3g or greater of protein in 24-hour urine collection
- Recent (within 48 weeks) or present hepatic decompensation with ascites/hydrothorax, hepatic encephalopathy or variceal bleeding
- Untreated chronic hepatitis B or C infection
- HCV eligible for enrollment if HCV RNA negative at baseline or documentation of prior SVR12
- HBV eligible if an HBV DNA \<100 IU/mL within the last 48 weeks and on treatment
- Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 200 U/L within the past 24 weeks or alkaline phosphatase (ALP) ≥ 300.
- Documented history of intolerance to statins
- Serious comorbid medical disease which in the investigator's opinion renders a life-expectancy less than 96 weeks
- Active illicit substance use (other than THC), including inhaled or injected drugs, in the 24 weeks prior to screening
- Pregnancy, planned pregnancy or breastfeeding
- 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.
- Significant existing muscle pain or tenderness or prior history of myasthenia gravis as determined by a site physician.
- Failure or inability to provide informed consent.
- East Asian Descent within one degree of relatedness (e.g., if the participant's parents are of East Asian descent)
The study team makes the final eligibility decision.
Where it is enrolling
- La Jolla, California, United States
- Los Angeles, California, United States
- San Francisco, California, United States
- Miami, Florida, United States
- Ann Arbor, Michigan, United States
- Rochester, Minnesota, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Cleveland, Ohio, United States
- Richmond, Virginia, United States
Compensation & support
A stipend or payment for your time may be offered.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at La Jolla, California, United States; Los Angeles, California, United States; San Francisco, California, United States; Miami, Florida, United States; Ann Arbor, Michigan, United States; Rochester, Minnesota, United States and 4 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.