[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"steatohepatitis-nonalcoholic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:steatohepatitis-nonalcoholic":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,45,77,105,132],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100613339","phase-3-using-hydroxychloroquine-hcq-to-treat-steatohepatitis-100613339",false,"NCT07265297","Using Hydroxychloroquine (HCQ) to Treat Steatohepatitis","A Randomized Controlled Trial of Using Hydroxychloroquine (HCQ) to Treat Steatohepatitis","Inclusion Criteria:\n\n1. Participants must be at least 18 years old.\n2. Participants must be able to return for scheduled follow-up visits during specific time points within the 12-month study period.\n3. Diagnosis of fatty liver confirmed by abdominal ultrasound or magnetic resonance imaging (MRI).\n4. Evidence of hepatic inflammation for more than three months, indicated by alanine aminotransferase (ALT) \\> 41 IU\u002FL.\n\nExclusion Criteria:\n\n1. Participants younger than 18 years old.\n2. Pregnant or breastfeeding women.\n3. Active viral hepatitis, determined by serum HBV or HCV viral load.\n4. Currently taking hydroxychloroquine (HCQ) for other medical conditions or indications.\n5. Known history of hypersensitivity or severe adverse drug reaction to HCQ.\n6. Presence of retinal maculopathy.","ALL","18 Years",{"count":19,"type":20},210,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","The goal of this clinical trial is to learn if drug hydroxychloroquine works to treat steatohepatitis in adults. It will also learn about the safety of drug hydroxychloroquine. The main questions it aims to answer are:\n\nDoes drug hydroxychloroquine improve steatohepatitis? What medical problems do participants have when taking drug hydroxychloroquine? Researchers will compare drug hydroxychloroquine to a placebo (a look-alike substance that contains no drug) to see if drug hydroxychloroquine works to treat steatohepatitis.\n\nParticipants will:\n\nTake drug hydroxychloroquine 400mg or hydroxychloroquine 200mg or placebo every day for 12 months Visit the clinic once every 3 months for checkups and tests",[26],"Steatohepatitis, Nonalcoholic",[28,29,30,31],"steatohepatitis","fatty liver","Hydroxychloroquine","Drug repurposing","RECRUITING","2025-12-01",{"date":35,"type":36},"2025-12-04","ACTUAL",{"date":38,"type":36},"2025-08-12",{"date":40,"type":20},"2030-12-31",{"name":42,"class":43},"National Taiwan University Hospital","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":57,"conditions":58,"keywords":61,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":44},"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":54,"type":20},50,[56],"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.",[59,26,60],"Non-Alcoholic Fatty Liver Disease","Liver Fibroses",[62,63,64,65,66],"Magnetic Resonance Imaging","Magnetic Resonance Spectroscopy","Diagnostic Ultrasound","Biopsy","Non-Inferiority Trial","2025-06-20",{"date":69,"type":36},"2025-06-25",{"date":71,"type":36},"2019-01-01",{"date":73,"type":20},"2026-12-31",{"name":75,"class":76},"Azienda USL Reggio Emilia - IRCCS","OTHER_GOV",{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":85,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":88,"phases":4,"briefSummary":89,"conditions":90,"keywords":91,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":44},"100591065","the-coherence-of-scatter-identification-and-exclusion-algorithm-study-100591065","NCT06975579","The COherence of Scatter Identification and Exclusion Algorithm Study","A Study of the COherence of Scatter Identification and Exclusion Algorithm: The COSIE Study","COSIE","Inclusion Criteria:\n\nHealthy Volunteers:\n\n* Healthy male or female adults (18 or above).\n* Volunteers must consider themselves fit and healthy.\n* RMH and\u002For ICR employees.\n\nPatients:\n\n* Patients undergoing liver MRI as part of clinical standard of care with evidence of steatosis on preceding MRI.\n* Aged 18 and above.\n\nExclusion Criteria:\n\nHealthy Volunteers:\n\n* Volunteers that are under investigation or planning to consult their GP to seek investigation for an undiagnosed condition, particularly regarding pelvic or abdominal disease or injury.\n* Healthy volunteers who do not have an NHS number or who are not registered with a GP will be excluded.\n\nPatients:\n\n• Severe liver fibrosis (fibrosis stage F4) or severe cirrhosis.",true,{"count":87,"type":20},15,"OBSERVATIONAL","Non-alcoholic fatty liver disease (NAFLD) is currently the most common liver condition worldwide; approximately 55% of the world population will have NAFLD by 2040. NAFLD is an unwanted side effect of common cancer therapies, such as chemotherapy. Ultrasound can detect NAFLD via measurement of the backscatter coefficient (BSC). It is an attractive technique because of its low cost and availability, potentially enabling earlier detection of NAFLD in a larger population through screening. This approach has shown promise in detecting NAFLD but is limited by variability in measurement due to several factors. Measurement of the BSC requires assumptions about the nature of the tissue being measured; if these assumptions are incorrect, they can lead to inaccurate BSC measurements. To improve accuracy, an algorithm (COSIE) was developed to quantify the suitability of tissue for BSC analysis. The investigators believe COSIE will enable more reliable BSC measurements by selecting the optimal regions of tissue to measure. By measuring the BSC in the livers of healthy volunteers and patients with evidence of fatty liver, the algorithm can be evaluated against liver fat percentage values obtained from MRI imaging. This study will assess whether applying the COSIE algorithm enhances the reliability of BSC measurements, bringing them closer in quality to MRI imaging.",[26],[92,93,94,95],"Liver ultrasound","backscatter coefficient","Non-alcoholic fatty liver disease","steatosis","2025-05-15",{"date":98,"type":36},"2025-05-16",{"date":100,"type":36},"2024-08-27",{"date":102,"type":20},"2025-06-30",{"name":104,"class":43},"Institute of Cancer Research, United Kingdom",{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":21,"phases":113,"briefSummary":114,"conditions":115,"keywords":118,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":44},"100557388","ketogenic-diet-in-masld-related-cacld-100557388","NCT06537466","Ketogenic Diet in MASLD-related cACLD","A Randomised Controlled Tria of Low-calorie Ketogenic Diet Versus Mediterranean Diet in Patients With Compensated Advanced Chronic Liver Disease (cACLD) Secondary to Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)","Inclusion Criteria:\n\n1. Patients older than 18 years\n2. Pattients with cACLD secondary MASLD. Specifically cACLD is defined as liver stiffness ≥10 KPa by Transient Elastography and\u002For fibrosis F3 or F4 at liver biopsy by Kleiner scoring system; MASLD is defined by the presence of steatosis and at least one of five cardiometabolic risk factor.\n3. Informed consent form obtained before any trial-related ac.vity.\n\nExclusion Criteria:\n\n1. Concomitance of any other chronic liver disease: Wilson's disease (normal serum ceruloplasmin); alpha-1-an.trypsin deficiency (normal serum alpha-1-an.trypsin); viral hepatitis (anti-HCV and HBsAg negativity); primary biliary cirrhosis (ANA\\<1:160 and AMA negativity); autoimmune hepatitis (ANA, SMA and LKM \\<1:160), . .\n2. MetALD: patients with metabolic dysfunc.on-associated steato.c liver disease, who consume amounts of alcohol per week (140-350 g\u002Fwk and 210-420 g\u002Fwk for females and males, respectively.\n3. History of or planned gastrointestinal bypass or any additional bariatric surgery\u002Fintervention.\n4. Recent significant weight loss ( \\> 5 % within previous 6 months)\n5. Presence of large esophageal varices (F2 or F3)\n6. Decompensated liver cirrhosis and\u002For presence of hepatocarcinoma and\u002For portal thrombosis.\n7. Be pregnant or breasxeeding.\n8. Type 1 diabetes, cardiac arrhythmias, recent stroke or myocardial infarction, heart failure, elective surgery or invasive procedures, chronic kidney disease (eGFR\\<30 ml\u002Fmin).\n9. Therapy with SGLT-2 inhibitors and\u002For GLP-1 agonist started within 6 months of screening visit.\n10. Recent (within 6 months of screening visit) or concomitant use of agents known to cause hepatic steatosis (corticosteroids, amiodarone, methotrexate, tamoxifen, tetracycline, high dose estrogens, valproic acid)\n11. Any additional condition that might interfere with optimal participation in the study, according to investigators opinion",{"count":54,"type":20},[56],"The investigators hypothesize that very low ketogenic diet could represent a new therapeutic option in the management of patients with MASLD and cACLD. Therefore, the investigator propose a randomized controlled study that evaluates the impact of two dietary protocols -Mediterranean diet, and very low ketogenic diet- the MD and the VLCKD, in individuals with cACLD secondary to MASLD.",[26,116,117],"Steatosis of Liver","Cirrhosis, Liver",[119,120,121],"Steatohepatitis","Steatosis","Ketogenic diet","NOT_YET_RECRUITING","2024-07-31",{"date":125,"type":36},"2024-08-05",{"date":127,"type":20},"2024-11",{"date":129,"type":20},"2026-11",{"name":131,"class":43},"University of Palermo",{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":85,"sex":139,"minAge":140,"maxAge":141,"enrollmentInfo":142,"targetDuration":4,"studyType":21,"phases":144,"briefSummary":146,"conditions":147,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":44},"100546884","phase-1-safety-of-dnp007-in-healthy-subjects-100546884","NCT06400771","Safety of DNP007 in Healthy Subjects","Exploratory, Single-dose, Phase I Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of DNP007 in Healthy Subjects","Inclusion Criteria:\n\n* A person whose weight at the time of the screening test is between 50.0 kg and 95 kg and whose body mass index (BMI) is between 18.0 kg\u002Fm2 and 30.0 kg\u002Fm2\n* After receiving sufficient explanation and fully understanding this clinical trial, I voluntarily decided to participate. A person who has made a decision and agreed in writing to follow the precautions\n* This test is determined by the examiner through physical examination, clinical laboratory tests, and questionnaires. Persons suitable as test subjects\n\nExclusion Criteria:\n\n* Clinically significant hepatobiliary system (severe liver failure, viral hepatitis, etc.), kidney (severe renal impairment, etc.), nervous system, immune system, respiratory system, endocrine system, blood\u002Ftumor, cardiovascular system (heart failure, etc.), urinary system, Those who have or have a history of mental illness (mood disorder, obsessive-compulsive disorder, etc.), sexual dysfunction, etc\n* Persons with a history of gastrointestinal disease (Crohn's disease, ulcer, gastritis, stomach cramps, gastroesophageal reflux disease, etc.) or surgery (excluding simple appendectomy or hernia surgery) that may affect the safety evaluation of clinical investigational drugs\n* Persons with a history of related allergy or hypersensitivity (including allergy to aspirin, antibiotics, vaccines, test drugs or their excipients)\n* C-reactive protein (CRP) and erythrocyte sedimentation rate in screening tests (ESR) exceeds 1.5 times the upper limit of normal range\n* Those with positive serological test results (hepatitis B test, hepatitis C test, human immunodeficiency virus (HIV) test, syphilis test\n* A person who has developed an infection or disease within 7 days prior to the first administration of the investigational drug (\"disease\" refers to an acute \\[severe or non-severe\\] condition \\[e.g., influenza or common cold, etc.\\])\n* Those who have a history of drug abuse or who have tested positive for drugs of abuse in a urine drug screening test\n* A person who has taken any prescription drug or herbal medicine within 2 weeks before the scheduled date of first administration of the investigational drug, or who has taken any over-the-counter drug (OTC drug) or health functional food or vitamin preparation including liver function supplements within 1 week (however, the investigator's Depending on the judgment, if other conditions are reasonable, you can be selected as a test subject) or a person who is expected to take the drug\n* Clinical trial drugs, barbiturates, etc. within 1 month before the first scheduled administration date. People who have taken drugs that induce drug-metabolizing enzymes or inhibit drug-metabolizing enzymes such as clarithromycin\n* Those who consumed grapefruit-containing foods such as grapefruit (grapefruit) or grapefruit juice from 3 days before the first scheduled administration of the investigational drug until the last discharge, and those who cannot refrain from consuming foods containing grapefruit (grapefruit) during the above period\n* Those who have unusual eating habits (e.g. drinking more than 1L of grapefruit juice per day) or who are unable to consume the standardized diet provided by the clinical trial center during hospitalization\n* Smokers (However, if you quit smoking 3 months or more before the scheduled date of first administration of the investigational drug, you can be selected as a test subject)\n* Those who continuously drink alcohol (exceeding 21 units\u002Fweek, 1 unit = 10 g of pure alcohol) or who are unable to abstain from drinking from 3 days before the first scheduled administration of the investigational drug until the last discharge\n* Continuously consumed excessive caffeine (more than 5 units\u002Fday) or consumed caffeine-containing foods (coffee, tea (black tea, green tea, etc.), carbonated beverages, coffee milk, nutritional supplements) during the period from 3 days before the first scheduled administration of the investigational drug until the last discharge. Those who cannot refrain from consuming tonic drinks, sports drinks, etc\n* A person who received an investigational drug by participating in another clinical trial (including a bioequivalence test) within 6 months before the scheduled date of first administration of the investigational drug\n* A person who has donated whole blood or component blood within 1 month within 2 months before the scheduled date of first administration of an investigational drug, or has received a blood transfusion\n* Those who are unable or unwilling to use a medically acceptable contraceptive method for themselves or their spouse (or partner) during the period before the clinical trial and at least 4 weeks after the last administration of the investigational drug, and those who do not agree not to donate sperm during that period\n* Other persons judged by the investigator to be unsuitable for participation in clinical trials","MALE","19 Years","55 Years",{"count":143,"type":20},12,[145],"PHASE1","This clinical trial evaluated the safety, tolerability, pharmacokinetic properties, and immunogenicity of DNP007 when administered as a single dose. Since this is a phase 1 study for exploratory evaluation, to the extent that it meets the study objectives, In order to proceed with the minimum number of subjects, a total of 12 people, 3 for each dose group, was planned as the target number.",[148,149,26],"Liver Transplant Rejection","Liver Transplant; Complications","2024-06-13",{"date":152,"type":36},"2024-06-18",{"date":154,"type":36},"2024-06-10",{"date":156,"type":20},"2024-12-31",{"name":158,"class":43},"Seoul National University Hospital"]