[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"liver-fibroses\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:liver-fibroses":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,41,73,98,128,156],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100413654","integrated-diagnostics-for-early-diagnosis-of-liver-disease-100413654",false,"NCT04666402","Integrated Diagnostics for Early Diagnosis of Liver Disease","ID LIVER","Inclusion Criteria:\n\n* All patients referred to Community Liver Assessment Clinic.\n* Male or female \\> 18 years of age.\n* Females will be non-pregnant and non-lactating.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years.\n* Pregnancy\u002Fbreast-feeding. Women of childbearing potential (not \\>2 years post- menopausal and\u002For not surgically sterilised) must have a negative blood serum pregnancy test.\n* Isolated bilirubinaemia.\n* Known pre-existing liver disease.\n* Acutely unwell.\n* Suspected malignancy.","ALL","18 Years",{"count":19,"type":20},1200,"ESTIMATED","OBSERVATIONAL","This is an observational study that will explore the hypothesis that by combining data from patients with liver disease with novel blood biomarkers, single nucleotide polymorphism (SNP) analysis and faecal microbiome analysis. The Investigators will improve diagnosis of liver fibrosis compared to the current available diagnostic tools.",[24,25,26,27],"Non-Alcoholic Fatty Liver Disease","Non-alcoholic Steatohepatitis","Alcoholic Liver Disease","Liver Fibroses","RECRUITING","2026-02-05",{"date":31,"type":32},"2026-02-09","ACTUAL",{"date":34,"type":32},"2020-10-21",{"date":36,"type":20},"2027-03-31",{"name":38,"class":39},"Manchester University NHS Foundation Trust","OTHER_GOV",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":72},"100441473","phase-2-safety-and-efficacy-of-atorvastatin-v-placebo-on-hcc-risk-100441473","NCT05028829","Safety and Efficacy of Atorvastatin v. Placebo on HCC Risk","Multi-center Double Blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Long-term Atorvastatin (20 mg\u002FDay) v. Placebo on HCC Risk in Individuals With Advanced Liver Fibrosis","TORCH","Inclusion Criteria:\n\n1. Willing and able to provide informed consent\n2. Male or female age \\> 18 years at time of consent\n3. Clinically or histologically diagnosed advanced liver fibrosis or cirrhosis, as defined by one or more of the following:\n\n   * Liver biopsy demonstrating advanced fibrosis or cirrhosis (METAVIR 3-4)\n   * Fibroscan or MR elastography consistent with advanced fibrosis or cirrhosis\n   * Imaging showing cirrhotic-appearing liver with signs of portal hypertension\n   * Advanced fibrosis or cirrhosis documented clinically by a treating physician\n4. High-risk for HCC at screening according to the FIB-4 index\n5. PLSec score ≥ 3 measured in screening blood samples from the FIB-4-high individuals.\n6. Liver imaging within 6 months of Day 1 is required in cirrhotic subjects only, to exclude HCC\n7. Female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception\n8. Willing and able to undergo protocol blood sampling\n9. Subject must be able to comply with dosing instructions for study drug administration and able to complete study schedule of assessments\n\nExclusion Criteria:\n\n1. Diagnosis of any of the following forms of chronic liver disease:\n\n   * alpha-1-antitrypsin (A1AT) deficiency, Wilson disease, hemochromatosis, iron overload, prior known or suspected drug-induced liver injury (DILI)\n   * Patients with PBC, PSC, AIH, or stable hemochromatosis may be included if their liver disease etiology overlaps with that of steatotic liver disease (SLD)\n2. Current or prior history of any of the following:\n\n   \\- Clinically significant illness or any other major medical disorder that in the opinion of the investigator, may interfere with subject treatment, assessment or compliance with the protocol\n3. Known positivity for HIV infection\n4. Active, untreated HCV infection\n\n   \\- Patients with prior history of HCV who achieved sustained virologic response (SVR) \\>12 from Day 1 may be included in the study\n5. Uncontrolled chronic HBV\n\n   \\- Patients with well controlled disease with \\>12 months of stable medication use (or no medication use, in those persons for whom anti-HBV therapy is not indicated)\n6. Clinical hepatic decompensation, defined as Child's Pugh class \\>B7 or C cirrhosis\n\n   \\- Patients with Child's Pugh score of 7, class B, may be included in the study\n7. History of biliary diversion\n8. Solid organ transplant\n9. Malignancy within the 5 years prior to screening, with the exception of specific cancers that have been cured by surgical resection (basal cell skin cancer, etc). Subjects under evaluation for possible malignancy are not eligible\n10. Pregnant or Nursing Females (a negative serum pregnancy test is required at screening for WOCBP)\n11. Life threatening SAE during the screening period\n12. Subjects having the following laboratory parameters at screening\n\n    * ALT \\> 10 x ULN\n    * AST \\> 10 x ULN\n    * Hemoglobin \\\u003C 8.5 g\u002Fdl\n    * Serum creatinine \\> 2.0 mg\u002FdL\n    * CK \\> 3x ULN\n13. Females who may wish to become pregnant and\u002For plan to undergo egg harvesting during the study and up to 30 days of the last dose of study drug\n14. WOCBP must abstain from breastfeeding and be willing to use effective birth control during through the week 4 post treatment follow-up visit\n15. Clinically relevant alcohol or drug abuse within 12 months of screening\n16. Use of any prohibited concomitant medications as described in Section 9.1.1\n17. Use of a statin medication within 90 days of Day 1 visit\n\n    \\- Subjects who are on a current statin at time of consent must be willing to undergo a 90-day washout period prior to randomization\n18. Known hypersensitivity to atorvastatin\n19. Current or planned participation in an investigational new drug (IND) trial from 30-days prior to randomization through the week 4 post treatment follow-up visit",{"count":50,"type":20},60,"INTERVENTIONAL",[53],"PHASE2","Prospective randomized, multi-center, double blind placebo-controlled trial to assess the chemopreventive impact of atorvastatin (20 mg oral) vs placebo in up to 60 adults with advanced fibrosis at high risk of developing HCC.",[27,56],"Cirrhosis",[58,59,60,61],"Liver Disease","Chemoprevention","HCC","Atorvastatin","2025-09-22",{"date":64,"type":32},"2025-09-23",{"date":66,"type":32},"2023-05-10",{"date":68,"type":20},"2031-03-01",{"name":70,"class":71},"Raymond Chung","OTHER",2,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":51,"phases":84,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":4},"100604111","phase-2-zinc-sulphate-in-treatment-fibrosis-in-hbv-patient-receiving-antiviral-therapy-100604111","NCT07145268","Zinc Sulphate in Treatment Fibrosis in HBV Patient Receiving Antiviral Therapy","Clinical Study to Evaluate the Possible Antifibrotic Effect of Zinc Sulphate in Chronic HBV Patient Receiving Anti Viral Therapy","HBV","Inclusion Criteria:\n\n* Patients with fibrosis stage (F2\\&F3) post chronic HBV infection receiving standard antiviral therapy.\n* Age \\> 18 and \\\u003C 65 years.\n\nExclusion Criteria:\n\n* Patients with prior history of liver transplantation.\n* Patients with prior history of hepatocellular carcinoma.\n* Patients coinfected with HIV or HCV.\n* Patients with any malignancies.\n* Pregnant and lactating women.","65 Years",{"count":83,"type":20},44,[53],"This study aims to investigate the possible safety and efficacy of Zinc sulphate as antifibrotic agent in chronic HBV patient receiving antiviral therapy.",[27,87],"HBV (Hepatitis B Virus)","NOT_YET_RECRUITING","2025-08-20",{"date":91,"type":32},"2025-08-28",{"date":93,"type":20},"2025-09-01",{"date":95,"type":20},"2026-09",{"name":97,"class":71},"Tanta University",{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":51,"phases":108,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":40},"100422830","accuracy-of-imaging-techniques-in-diagnosing-steatohepatitis-and-fibrosis-in-nafld-patients-100422830","NCT04785937","Accuracy of Imaging Techniques in Diagnosing Steatohepatitis and Fibrosis in NAFLD Patients","Accuracy of Imaging Techniques Including Ultrasound and Magnetic Resonance Imaging in the Diagnosis of Steatohepatitis and Fibrosis in Patients With Non-Alcoholic Fatty Liver Disease: Comparison With the Histological Reference Standard","ImagingNAFLD","Inclusion Criteria:\n\n* clinical indication to perform a liver biospy for NAFLD assessment based on all of the following:\n\n  1. presence of liver steatosi at ultrasound\n  2. at least one risk factor for NASH\u002Ffibrosis (obesity, or type 2 diabetes mellitus, or metabolic syndrome)\n  3. increased liver enzymes (at least one of: GOT\\>40 U\u002Fl, GPT\\>49 U\u002Fl, GGT\\>75 U\u002Fl) or high NAFLD fibrosis score (\\>0.675), or intermediate NAFLD fibrosis score (between -1.455 and 0.675) and increased liver stiffness at transient elastography (\\>7 KPa).\n* consent to participate in the study\n\nExclusion Criteria:\n\n* age \\\u003C 18 years\n* secondary causes of liver steatosis (moderate to severe alcohol consumption, steatogenic drugs)\n* known diffuse liver diseases other than NAFLD (cirrhosis, viral or autoimmune hepatitis, hemochromatosis, amiloidosis, other) or previous primary or secondary liver neoplasms\n* contraindications to perform liver biopsy (ascites, platelet count\\\u003C50.000\u002Fmmc, INR\\>1.5, PT\\>50%, serum bilirubin \\>3 mg\u002FdL)\n* contraindications to perform magnetic resonance (pace-maker, claustrophobia, pregnancy, MR-unsafe metallic implants)",{"count":107,"type":20},50,[109],"NA","Non-alcoholic fatty liver disease (NAFLD) is a highly prevalent condition, and when fatty liver is associated with inflammation and hepatocellular injury (steatohepatitis), it can lead to fibrosis, cirrhosis, liver failure and hepatocellular carcinoma. Liver biopsy is the gold standard for NAFLD assessment but has several drawbacks. Several drugs for NASH are now in phase 2-3 trials, and if medical treatments become available, non-invasive tools to identify patients who may benefit from a therapeutic intervention will be strongly needed. Some imaging methods have shown promising potential in fibrosis and NASH diagnosis. This study aims to evaluate the diagnostic accuracy of non-invasive imaging methods, including ultrasound (US) and Magnetic Resonance (MR) techniques, in diagnosing NASH and fibrosis in patients with or at high risk of NAFLD, using liver biopsy as the reference standard. Consecutive patients with a clinical indication for liver biopsy assessment of NAFLD are enrolled in this non-inferiority study. They undergo both a liver US and a multiparametric unenhanced liver MR examination. As reference standard, histological diagnosis of fibrosis and steatohepatitis made according to the fatty liver inhibition of progression (FLIP) algorithm is used. Sensitivity and specificity of imaging parameters alone or in different combinations will be calculated with the aim of finding one or more tests with at least 90% sensitivity\u002Fspecificity compared to liver biopsy.",[24,112,27],"Steatohepatitis, Nonalcoholic",[114,115,116,117,118],"Magnetic Resonance Imaging","Magnetic Resonance Spectroscopy","Diagnostic Ultrasound","Biopsy","Non-Inferiority Trial","2025-06-20",{"date":121,"type":32},"2025-06-25",{"date":123,"type":32},"2019-01-01",{"date":125,"type":20},"2026-12-31",{"name":127,"class":39},"Azienda USL Reggio Emilia - IRCCS",{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":136,"enrollmentInfo":137,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":139,"conditions":140,"keywords":144,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":40},"100365292","liver-damage-and-cardiometabolic-disorders-in-nafld-100365292","NCT04036357","Liver Damage and Cardiometabolic Disorders in NAFLD","Progression of LIver Damage and Cardiometabolic Disorders in Non-alcoholic Fatty Liver dIsease: an Observational Cohort STUDY. The Plinio Study","PLINIO","Inclusion Criteria:\n\n* Patients aged 18 years old or more\n* Patients with at least on of the following metabolic disorders\n\n  * Obesity\n  * Diabetes\n  * Arterial hypertension\n  * Dyslipidemia\n\nExclusion Criteria:\n\n* Average daily consumption of alcohol \\>20 g in women and of \\>30 g in men (assessed by Alcohol Use Disorders Identification Test, AUDIT;\n* presence of hepatitis B surface antigen and antibody to hepatitis C virus;\n* positive tests for autoimmune hepatitis;\n* cirrhosis and other chronic liver diseases;\n* diagnosis of oncological diseases\n* concomitant therapy with drugs known to promote liver steatosis (e.g. amiodarone);\n* other chronic infectious or autoimmune disease;","80 Years",{"count":138,"type":20},2000,"Liver fibrosis is the most important prognostic factor in patients with non-alcoholic factor disease. Clinical and biological condition, as diabetes or mutation for PNPLA3, are well known factors associated with liver fibrosis onset and progression. However, little is known about biochemical factors predicting liver fibrosis evolution in large NAFLD populations.",[141,27,142,143],"NAFLD","Cardiovascular Diseases","Cardiovascular Risk Factor",[141,145,146],"Liver fibrosis","Cardiovascular","2019-08-13",{"date":149,"type":32},"2019-08-16",{"date":151,"type":32},"2011-11",{"date":153,"type":20},"2036-12-31",{"name":155,"class":71},"University of Roma La Sapienza",{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":4,"eligibilityCriteria":162,"healthyVolunteers":11,"sex":16,"minAge":163,"maxAge":4,"enrollmentInfo":164,"targetDuration":4,"studyType":51,"phases":166,"briefSummary":160,"conditions":168,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":40},"100344918","phase-3-effect-of-some-drugs-on-liver-fibrosis-100344918","NCT03770936","Effect of Some Drugs on Liver Fibrosis","Clinical Study Evaluating the Efficacy of Renin Angiotensin System Inhibitors on the Extent of Liver Fibrosis in Patients With Chronic Hepatitis C","Inclusion Criteria:\n\n* chronic hepatitis C\n\nExclusion Criteria:\n\n* Acute hepatitis\n* Thalassemia","20 Years",{"count":165,"type":20},45,[167],"PHASE3",[27],"2018-12-07",{"date":171,"type":32},"2018-12-10",{"date":173,"type":32},"2018-10-01",{"date":175,"type":20},"2027-11",{"name":177,"class":71},"Sherief Abd-Elsalam"]