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Tests treatment safety and results for Cirrhosis
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?
Rosuvastatin is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for cirrhosis.
Also referred to as Rosuvastatin 20 mg, Rosuvastatin 10 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 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.
- 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 nonalcoholic steatohepatitis, alcohol-associated liver disease, or chronic viral hepatitis (treated hepatitis B virus or hepatitis C...
- Clinical diagnosis of cirrhosis as defined investigator confirmation and the following:
- At least one liver biopsy within 5 years prior to consent showing either: Metavir stage 4 fibrosis; Ishak Stage 5-6 fibrosis, OR
- At least 2 of the following: i. Evidence on imaging: Nodular liver with either splenomegaly or recanalized umbilical vein within the past 48 weeks...
You likely can't join if
- Currently on a statin or any statin exposure within 24 weeks prior to consent.
- Known indication for statin therapy, defined as:
- 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.
See the full eligibility criteria
- 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)
- Clinical diagnosis of cirrhosis as defined investigator confirmation and the following:
- At least one liver biopsy within 5 years prior to consent showing either: Metavir stage 4 fibrosis; Ishak Stage 5-6 fibrosis, OR
- At least 2 of the following: i. Evidence on imaging: Nodular liver with either splenomegaly or recanalized umbilical vein within the past 48 weeks ii. Liver stiffness: vibration-controlled transient elastography within...
- Two measures of vibration-controlled transient elastography: one at screening and one at the randomization study visit, meeting the following criteria:
- The first measure must be ≥ 15 kilopascal.
- 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 kilopascal.
- Additionally, both screening and open-label dispense liver stiffness measures must be ≤50 kPa
- Compensated defined by:
- 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.
- Known indication for statin therapy, defined as:
- 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.
- Current (in past 24 weeks prior to consenting) use of medications known to cause hepatic fibrogenesis or confound endpoint assessment, defined as:
- amiodarone
- methotrexate
- warfarin
- Current (in past 24 weeks prior to consenting) use of medications which may increase risk for rosuvastatin-related myositis or DILI, defined as:
- fenofibrate
- erythromycin
- gemfibrozil
- niacin (500 mg or more)
- HIV protease inhibitors (darunivar, indinavir, nelfinavir, amprenavir) in patients of East Asian descent
- colchicine
- cyclosporin
- Additional medications that will be excluded: atazanavir/ritonavir capmatinib darolutamide dasabuvir/ombitasvir/paritaprevir/ritonavir ledipasvir/sofosbuvir elbasvir/grazoprevir erythromycin glecaprevir/pibrentasvir...
- 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:
- Unstable or active inflammatory bowel disease
- Active infection
- Any malignant disease (other than squamous or basal cell carcinoma of the skin) within previous 3 years
- Prior solid organ or hematopoietic cell transplant
- Bariatric surgery in the last 24 weeks prior to consent or planned bariatric surgery within the next 96 weeks
- Current liver-unrelated end-stage organ failures such as end-stage renal disease on dialysis, stage 3-4 congestive heart failure (CHF), current chronic obstructive pulmonary disease (COPD) on home oxygen.
- 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:
- Hemoglobin \<10 g/dL
- Albumin \<3.0 g/dL
- Prolonged international normalized ratio (INR) \>1.5
- Total bilirubin ≥ 2.0 mg/dl (unless due to Gilbert's syndrome or hemolysis as denoted by normal direct bilirubin fraction)
- Direct bilirubin ≥ 0.9
- Uncontrolled diabetes (HbA1c ≥ 9.5%) within past 90 days.
- Kidney function abnormalities including:
- 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, or alkaline phosphatase (ALP) ≥ 300 within the past 24 weeks.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- 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 compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
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 - 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 - 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?
Study sites include 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 location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.