[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cirrhosis-due-to-hepatitis-c\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cirrhosis-due-to-hepatitis-c":35},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,52],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":36,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100503205","phase-2-liver-cirrhosis-network-rosuvastatin-efficacy-and-safety-for-cirrhosis-in-the-united-states-100503205",false,"NCT05832229","Liver Cirrhosis Network Rosuvastatin Efficacy and Safety for Cirrhosis in the United States","Liver Cirrhosis Network (LCN) Rosuvastatin Efficacy and Safety for Cirrhosis in the United States (RESCU): A Double-Blind Randomized, Placebo-Controlled Phase 2 Study","LCN RESCU","Inclusion Criteria:\n\n1. Age 18-75 years\n2. Cirrhosis due to nonalcoholic steatohepatitis, alcohol-associated liver disease, or chronic viral hepatitis (treated hepatitis B virus or hepatitis C virus)\n3. Clinical diagnosis of cirrhosis as defined investigator confirmation and the following:\n\n   1. At least one liver biopsy within 5 years prior to consent showing either: Metavir stage 4 fibrosis; Ishak Stage 5-6 fibrosis, OR\n   2. At least 2 of the following:\n\n   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 48 weeks prior to consent or during Screening ≥15 kilopascal or magnetic resonance elastography within 48 weeks prior to consent or during Screening ≥5 kilopascal iii. Evidence of varices demonstrated on imaging or endoscopy within 3 years prior to consent or during Screening iv. Either: Fibrosis-4\\>2.67 or platelets \\<150\u002FmL within 6 months prior to consent or during Screening\n4. Two measures of vibration-controlled transient elastography: one at screening and one at the randomization study visit, meeting the following criteria:\n\n   1. The first measure must be ≥ 15 kilopascal.\n   2. The two measures must be at least 2 hours apart and no more than 60 days apart from one another.\n   3. The mean of two measurements must be ≥ 15 kilopascal.\n   4. Additionally, both screening and open-label dispense liver stiffness measures must be ≤50 kPa\n5. Compensated defined by:\n\n   1. Absence of ascites\u002Fhydrothorax, hepatic encephalopathy or variceal bleeding currently or in the last 48 weeks, as determined clinically by investigator.\n   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\u002For rifaximin or lactulose for the treatment of hepatic encephalopathy. Use of non-selective beta blockers will be allowed.\n   3. Child-Pugh score \\<8\n6. Provision of written informed consent.\n\nExclusion Criteria:\n\n1. Currently on a statin or any statin exposure within 24 weeks prior to consent.\n2. Known indication for statin therapy, defined as:\n\n   1. Prior peripheral vascular, cardiovascular or cerebrovascular event for which statins are indicated for secondary prevention, OR\n   2. Documented familial hypercholesterolemia, heterozygous familial hypercholesterolemia, OR\n   3. Fasting LDL-C ≥ 190 mg\u002FdL\n3. Myocardial infarction, Unstable angina, transient ischemic events, or stroke within 24 weeks of screening.\n4. Alcohol Use Disorder Identification Test (AUDIT) total score of ≥8 at screening.\n5. Patients with limitations in attending study visits.\n6. Prisoners.\n7. Known prior or current hepatocellular carcinoma (HCC) or cholangiocarcinoma.\n8. Known transjugular intrahepatic portosystemic shunt (TIPS), balloon retrograde transvenous obliteration (BRTO) or porto-systemic shunt surgery regardless of time of occurrence.\n9. Current (in past 24 weeks prior to consenting) use of medications known to cause hepatic fibrogenesis or confound endpoint assessment, defined as:\n\n   1. amiodarone\n   2. methotrexate\n   3. warfarin\n10. Current (in past 24 weeks prior to consenting) use of medications which may increase risk for rosuvastatin-related myositis or DILI, defined as:\n\n    1. fenofibrate\n    2. erythromycin\n    3. gemfibrozil\n    4. niacin (500 mg or more)\n    5. HIV protease inhibitors (darunivar, indinavir, nelfinavir, amprenavir) in patients of East Asian descent\n    6. colchicine\n    7. cyclosporin\n    8. Additional medications that will be excluded:\n\n    atazanavir\u002Fritonavir capmatinib darolutamide dasabuvir\u002Fombitasvir\u002Fparitaprevir\u002Fritonavir ledipasvir\u002Fsofosbuvir elbasvir\u002Fgrazoprevir erythromycin glecaprevir\u002Fpibrentasvir lopinavir\u002Fritonavir regorafenib ritonavir, in any combination simeprevir sofbuvir\u002Fvelpatasvir\u002Fvoxilaprevir sofosbuvir\u002Fvelpatasvir tafamidis teriflunomide\n\n    \\*If exposure was for 7 or less days for one of these medications can consider enrollment after 28 days from final dose.\n11. Presence of portal or hepatic vein thrombosis\n12. Diagnosis of untreated hypothyroidism or on unstable treatment regimen for hypothyroidism\n13. Receiving an elemental diet or parenteral nutrition\n14. Chronic pancreatitis or pancreatic insufficiency\n15. 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 disease, etc.)\n16. Conditions which may confound study outcome:\n\n    1. Unstable or active inflammatory bowel disease\n    2. Active infection\n    3. Any malignant disease (other than squamous or basal cell carcinoma of the skin) within previous 3 years\n    4. Prior solid organ or hematopoietic cell transplant\n    5. Bariatric surgery in the last 24 weeks prior to consent or planned bariatric surgery within the next 96 weeks\n    6. 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.\n17. 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.\n18. The following laboratory abnormalities within 90 days of screening:\n\n    1. Hemoglobin \\\u003C10 g\u002FdL\n    2. Albumin \\\u003C3.0 g\u002FdL\n    3. Prolonged international normalized ratio (INR) \\>1.5\n    4. Total bilirubin ≥ 2.0 mg\u002Fdl (unless due to Gilbert's syndrome or hemolysis as denoted by normal direct bilirubin fraction)\n    5. Direct bilirubin ≥ 0.9\n    6. Uncontrolled diabetes (HbA1c ≥ 9.5%) within past 90 days.\n19. Kidney function abnormalities including:\n\n    1. Dialysis\n    2. Baseline eGFR \\\u003C 30 cc\u002Fmin with CKD-Epi equation\n    3. Known nephrotic proteinuria, defined as 3g or greater of protein in 24-hour urine collection\n20. Recent (within 48 weeks) or present hepatic decompensation with ascites\u002Fhydrothorax, hepatic encephalopathy or variceal bleeding\n21. Untreated chronic hepatitis B or C infection\n\n    1. HCV eligible for enrollment if HCV RNA negative at baseline or documentation of prior SVR12\n    2. HBV eligible if an HBV DNA \\\u003C100 IU\u002FmL within the last 48 weeks and on treatment\n22. Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 200 U\u002FL, or alkaline phosphatase (ALP) ≥ 300 within the past 24 weeks.\n23. Documented history of intolerance to statins\n24. Serious comorbid medical disease which in the investigator's opinion renders a life-expectancy less than 96 weeks\n25. Active illicit substance use (other than THC), including inhaled or injected drugs, in the 24 weeks prior to screening\n26. Pregnancy, planned pregnancy or breastfeeding\n27. 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.\n28. Significant existing muscle pain or tenderness or prior history of myasthenia gravis as determined by a site physician.\n29. Failure or inability to provide informed consent.","ALL","18 Years","75 Years",{"count":21,"type":22},256,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","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.",[28,29,30,31,32,33,34,35],"Cirrhosis","Cirrhosis, Liver","Cirrhosis Early","Cirrhosis Due to Hepatitis B","Cirrhosis Advanced","Cirrhosis Infectious","Cirrhosis Alcoholic","Cirrhosis Due to Hepatitis C",[28,37,38],"Liver","Nonalcoholic Fatty Liver Disease","RECRUITING","2026-05-29",{"date":42,"type":43},"2026-06-02","ACTUAL",{"date":45,"type":43},"2023-12-07",{"date":47,"type":22},"2029-08-31",{"name":49,"class":50},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH",13,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":62,"conditions":63,"keywords":67,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":5},"100566715","abbreviated-magnetic-resonance-imaging-vs-ultrasound-surveillance-for-liver-cancer-detection-in-people-at-high-risk-of-developing-liver-cancer-100566715","NCT06658782","Abbreviated Magnetic Resonance Imaging vs Ultrasound Surveillance for Liver Cancer dETection in People at High Risk of Developing Liver Cancer","AMULET","Inclusion Criteria:\n\n* • Participant is willing and able to give informed consent for participation in the study AND\n\n  * All genders, aged 18 years or above AND\n  * Eligible for HCC US surveillance in the opinion of the local investigators AND\n  * Child Pugh score A or B AND\n  * Diagnosed with liver cirrhosis due to ArLD, MASLD, chronic hepatitis C, chronic hepatitis B, genetic haemochromatosis AND\n  * Have an annual risk of HCC of at least 3% as determined by the aMAP score OR\n  * Participants with chronic liver disease (with or without cirrhosis) who had successful treatment for HCC, have not had a recurrence and have returned to 6 monthly surveillance with USS\n\nExclusion Criteria:\n\n* • Contraindication to MRI\n\n  * Known allergy \u002F reaction to intravenous gadolinium contrast\n  * Prisoners\n  * Pregnancy or breast feeding\n  * Previous liver transplant\n  * Participants who are known to have indeterminate liver nodules on prior imaging requiring ongoing follow-up with MRI or CT\n  * Previous HCC treated with curative intent and still being followed up with CT or MRI with contrast for possible recurrence\n  * Estimated glomerular filtration rate of \\\u003C30 ml\u002Fmin\u002F1.73m2\n  * Participant is on haemodialysis\n  * Participants who are unlikely to comply with the study procedures in the opinion of the local investigator\n  * In the view of the clinician, if the participant has a co-morbidity likely to lead to death within the following 12 months",{"count":60,"type":22},300,"OBSERVATIONAL","Aim: To use magnetic resonance imaging (MRI) scans without contrast to help improve diagnosis of liver cancer in people who are at increased risk of developing liver cancer.\n\nBackground: People with any condition that affects the liver over a long period of time can develop cirrhosis. Conditions and risk factors that can lead to cirrhosis include alcohol excess, liver steatosis (lipid or fat accumulation in the liver) and infection with the viruses hepatitis B and C. One of the concerns about people with cirrhosis is that they are at increased risk of developing liver cancer. People with cirrhosis are recommended to have an ultrasound scan (USS) every 6 months (surveillance for liver cancer) so that if a cancer develops, it is diagnosed at an early stage when it can be cured. However, ultrasound can miss cancers even in people having scans every 6 months. Furthermore, the risk of cancer is not alike among people with cirrhosis. For example, people with more advanced cirrhosis and those with cirrhosis from hepatitis B are at higher risk. It is therefore possible that better tests than ultrasound are needed for people with cirrhosis who are at particularly high risk of developing cancer.\n\nComputed tomography (CT) and Magnetic Resonance Imaging (MRI) scans with dye injection (contrast) are used for liver cancer diagnosis. However, they cannot be done every 6 months because of costs, capacity and toxicity from high CT radiation doses, and MRI contrast build-up in the brain with repeated MRI contrast injections. MRI scans without contrast are not toxic, could be done in 20 minutes and are cheaper, so could be done every 6 months. In the experience of the study investigators, MRI without contrast may raise suspicion of liver cancer in cases missed by ultrasound, so it could be used for surveillance instead of ultrasound. This study aims to find out if it is feasible to use a quick MRI (20 minutes) without contrast as surveillance for liver cancer in people at high risk of liver cancer due to liver cirrhosis and to compare this MRI with ultrasound.\n\nDesign and Methods: The investigators will recruit 300 people at higher risk of developing liver cancer because of cirrhosis. Study participants will have an ultrasound scan every 6 months as they would in their standard clinical care and an additional 6 monthly non-contrast MRI scan for 30 months (6 visits). If the ultrasound or non-contrast MRI raises concern for a possible liver cancer, an MRI scan with contrast (with dye injection) will be done for definitive diagnosis. All participants will have an MRI with contrast at the end of 30 months (M30) to ensure that no cancers were missed. Participants will be asked to complete questionnaires to measure quality of life, anxiety, and their experience of MRI and ultrasound scans and data will be collected from their medical notes. The number of liver cancers detected by ultrasound will be compared to the number detected by the non-contrast MRI scans.",[28,31,64,35,65,66],"Cirrhosis and Chronic Liver Disease","Cirrhosis of the Liver","Hepatocellular Carcinoma",[68,69,70,71],"SURVEILANCE","DIAGNOSTIC ACCURACY","abbreviated MRI","no contrast enhanced MRI","2025-09-17",{"date":74,"type":43},"2025-09-22",{"date":76,"type":43},"2025-05-01",{"date":78,"type":22},"2039-04-30",{"name":80,"class":81},"University of Oxford","OTHER"]