[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"liver-fibrosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:liver-fibrosis":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,41,0,25,[9,42,78,111,139,163,187,213,263,299,330,350,376,404,426,456,479,498,521,548,572,597,618,642,661],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100564689","liverage-a-study-to-test-whether-survodutide-helps-people-with-a-liver-disease-called-nashmash-who-have-moderate-or-advanced-liver-fibrosis-100564689",false,"NCT06632444","LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH\u002FMASH Who Have Moderate or Advanced Liver Fibrosis","A Randomised, Double-blind, Placebo-controlled, Multicentre, Phase III Trial Evaluating Long-term Efficacy and Safety of Survodutide Weekly Injections in Adult Participants With Noncirrhotic Non-alcoholic Steatohepatitis\u002FMetabolic Dysfunction-associated Steatohepatitis (NASH\u002FMASH) and (F2) - (F3) Stage of Liver Fibrosis","Inclusion criteria:\n\n1. Male or female participants ≥18 years (or who are of legal age in countries where that is greater than 18 years) of age at time of consent\n2. Diagnosis of MASH (non-alcoholic fatty liver disease (NAFLD)) activity score \\[NAS\\] ≥4\n3. Stable body weight defined as less than 5% self-reported change in body weight 3 months prior to the screening or during the period between the historical biopsy and randomisation, if a historical biopsy is used\n4. Be willing to maintain a stable diet and physical activity levels throughout the entire trial Further inclusion criteria apply\n\nExclusion criteria:\n\n1. Any of the following liver laboratory test abnormalities at screening:\n\n   * Serum AST and\u002For alanine aminotransferase (ALT) elevation ≥5x upper limit of normal (ULN)\n   * Platelet count \\\u003C140 000\u002Fmm\\^3 (\\\u003C140 GI\u002FL)\n   * Alkaline phosphatase \\>2x upper limit of normal (ULN)\n   * Abnormal synthetic liver function as defined by screening central laboratory evaluation:\n\n     * Albumin below \\\u003C3.5 g\u002FdL (35.0 g\u002FL)\n     * OR International normalised ratio (INR) of prothrombin time \\>1.3\n     * OR total serum bilirubin concentration ≥1.5x ULN\n2. Any history or evidence of acute or chronic liver disease other than MASH\n3. Histologically documented liver cirrhosis (fibrosis stage F4), either at screening or in a historical biopsy\n4. History of or current diagnosis of hepatocellular carcinoma\n5. History of or planned liver transplant\n6. Inability or unwillingness to undergo a liver biopsy at screening (if a suitable historical biopsy is unavailable for central review), or during trial conduct.\n7. History of portal hypertension or presence of decompensated liver disease\n8. Model for end-stage liver disease (MELD) score ≥12 due to liver disease. Further exclusion criteria apply","ALL","18 Years",{"count":20,"type":21},1800,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This study is open to adults who are at least 18 years old living with obesity and have:\n\n* a confirmed liver disease called non-alcoholic steatohepatitis (NASH)\u002Fmetabolic associated steatohepatitis (MASH) and\n* moderate or advanced liver fibrosis\n\nPeople with a history of acute or chronic liver diseases other than MASH or chronic alcohol intake cannot take part in this study. The purpose of this study is to find out whether a medicine called survodutide helps people with MASH and moderate or advanced liver fibrosis improve their liver function.\n\nThis study has 2 parts. The purpose of the first part of this study is to find out the effect of survodutide on MASH and liver fibrosis. The purpose of the second part is to find out how safe and effective survodutide is in improving liver function. Participants are put into 2 groups randomly, which means by chance. 1 group gets survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Each participant has twice the chance of getting survodutide. Participants and doctors do not know who is in which group. Participants inject survodutide or placebo under their skin once a week. The survodutide doses are slowly increased until the target dose is reached. All participants receive counselling to make changes to their diet and to exercise regularly.\n\nParticipants are in the study for up to 7 years. During this time, they regularly visit the study site or have remote visits by video call. For about the first year of the study, participants have these visits every 2 weeks, increasing to every 4 weeks and then every 6 weeks. After being in the study for a little over a year participants will then alternate between visiting the study site or having a remote visit every 3 months until the end of the study.\n\nThe doctors check participants' health and take note of any unwanted effects. The participants' body weight and effects on the stomach and intestines are regularly measured. At some visits the liver is measured using different imaging methods. At 2 or 3 visits doctors take a small sample of liver tissue (biopsy). The participants also fill in questionnaires about their symptoms and quality of life. The results are compared between the groups to see whether the treatment works.",[27,28],"Metabolic Dysfunction Associated Steatohepatitis (MASH)","Liver Fibrosis","RECRUITING","2026-08-20",{"date":32,"type":33},"2026-08-21","ACTUAL",{"date":35,"type":33},"2024-10-14",{"date":37,"type":21},"2031-12-27",{"name":39,"class":40},"Boehringer Ingelheim","INDUSTRY",528,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":77},"100649188","isocaloric-navy-bean-substitution-in-adults-with-masld-100649188","NCT07730853","Isocaloric Navy-Bean Substitution in Adults With MASLD","Randomized Feasibility Trial of Isocaloric Navy-Bean Substitution in Adults With MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)","BEAN-MASLD","Inclusion Criteria:\n\n* Adults 18-75 years of age with capacity to provide informed consent\n* Clinical diagnosis of MASLD, confirmed by imaging (MRI-PDFF or VCTE) or prior liver biopsy.\n* Intermediate-stage fibrosis (F2-F3) confirmed by one of the following (most recent qualifying result): VCTE (FibroScan) 8.0-14 kPa, MRE 3.0-4.6 kPa (2D EPI @ 60 Hz), or liver biopsy read as F2-F3\n* Body mass index 25-45 kg\u002Fm²\n* Stable medications for ≥12 weeks for diabetes, hypertension, dyslipidemia, or weight management\n* Alcohol intake below MASLD thresholds (≤15 drinks\u002Fweek for men, ≤10 drinks\u002Fweek for women)\n* Willing and able to consume study navy beans and complete dietary recalls (ASA-24\u002FDSQ)\n* Able to undergo MRI and MRE (no contraindications) and attend study visits\n* Agrees to biospecimen collection (blood, stool, saliva) and patient-reported outcomes\n\nExclusion Criteria:\n\n* Other chronic liver disease (hepatitis B, hepatitis C, autoimmune hepatitis, hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, primary biliary cholangitis, primary sclerosing cholangitis)\n* Decompensated liver disease (ascites, variceal bleeding, encephalopathy) or Child-Pugh B\u002FC cirrhosis, or clinical portal hypertension\u002Fdecompensation\n* Heavy alcohol use above MASLD thresholds, or alcohol use disorder within 12 months\n* Legume\u002Fbean allergy or intolerance\n* Initiation or dose change of antidiabetic, lipid-lowering, antihypertensive, or weight-loss medications within the past 12 weeks, or anticipated changes during the trial\n* Recent initiation of agents known to affect hepatic fat or fibrosis (e.g., GLP-1 receptor agonist, SGLT2 inhibitor, pioglitazone, resmetirom) within 12 weeks\n* Use of hepatotoxic drugs likely to confound liver enzymes in the prior 12 weeks (per investigator judgment)\n* New supplements targeting weight loss, liver health, or the microbiome within 8-12 weeks (e.g., berberine, high-dose omega-3, pre\u002Fprobiotics)\n* Antibiotics, probiotics, or colonoscopy preparation within 8 weeks\n* Planned bariatric surgery or other major weight-loss intervention during the study\n* Recent weight change \\>5% within 8-12 weeks prior to baseline\n* Severe gastrointestinal disease (inflammatory bowel disease, celiac disease, short bowel syndrome) that may impair tolerance\n* Uncontrolled diabetes (HbA1c \\>10%), severe renal dysfunction (eGFR \\\u003C45), or unstable cardiovascular, thyroid, or psychiatric illness\n* Pregnant or breastfeeding\n* Contraindications to MRI (e.g., non-compatible implants, severe claustrophobia)\n* Participation in another interventional study within the last 30 days","75 Years",{"count":52,"type":21},40,[54],"NA","This study is a 24-week randomized crossover feasibility trial evaluating an isocaloric navy-bean dietary substitution in 40 adults with metabolic dysfunction-associated steatotic liver disease (MASLD) and intermediate-stage (F2-F3) fibrosis. Participants are randomized to one of two sequences-habitual diet followed by a navy-bean-rich diet, or a navy-bean-rich diet followed by habitual diet-with each 12-week phase guided by registered dietitians so that navy beans replace an equivalent caloric load without changing total energy intake. The primary aim is to establish feasibility and acceptability, measured by recruitment and retention, adherence with biomarker (plasma pipecolic-acid) concordance, and patient acceptability.",[57,28,58],"Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)","Metabolic Dysfunction-Associated Steatohepatitis (MASH)",[60,61,62,63,64,65],"Navy beans","Dietary intervention","Isocaloric substitution","Gut microbiome","Gut-liver axis","Liver stiffness","NOT_YET_RECRUITING","2026-08-10",{"date":69,"type":33},"2026-08-12",{"date":71,"type":21},"2026-09-01",{"date":73,"type":21},"2029-08-31",{"name":75,"class":76},"Icahn School of Medicine at Mount Sinai","OTHER",1,{"id":79,"slug":80,"hasResults":12,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":12,"sex":17,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":4,"studyType":22,"phases":90,"briefSummary":92,"conditions":93,"keywords":97,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":77},"100650974","different-treatment-frequencies-for-hepatic-fibrosis-due-to-schistosomiasis-an-rct-100650974","NCT07754617","Different Treatment Frequencies for Hepatic Fibrosis Due to Schistosomiasis","An RCT to Evaluate Different Treatment Approaches to Mitigate the Progression of Schistosomiasis Related Hepatic Fibrosis","SchiFT","Inclusion Criteria:\n\n1. S. mansoni infection as determined by urine Circulating Cathodic Antigen (CCA)\n2. Otherwise healthy as determined by history and physical examination conducted by the study clinician\n3. Not Pregnant\n4. Age 15-40 years\n5. Consent for individuals 18 years of age and older, and parental consent and adolescent assent for participants ages 15-17 years.\n6. The presence of hepatic fibrosis due to S. mansoni (Niamey protocol grade C-F) and compensated (without late-stage portal hypertension) after ruling out other causes of hepatic fibrosis as below.\n\nExclusion Criteria:\n\n1. . History of upper gastrointestinal bleeding\n2. Hepatic fibrosis that is not deemed to be due to schistosomiasis based on ultrasound and hepatitis serologies. For example, alcoholic cirrhosis or presence of chronic Hepatitis B or C by point of care test\n3. Known neurocysticercosis or ocular cysticercosis","15 Years","40 Years",{"count":89,"type":21},600,[91,24],"PHASE2","The goal of this clinical trial is to learn if treating individuals living in Uganda who have liver fibrosis (scarring) due to schistosomiasis would benefit from more frequent treatment with drug praziquantel. This drug is already approved to treat schistosomiasis and is used globally. The study will include individuals who have schistosomiasis and some degree of liver fibrosis. The main questions it aims to answer are:\n\n1. Does treating participants three times per year as compared to once per year as currently recommended improve the likelihood the hepatic fibrosis will improve over three years.\n2. Does treating participants three times per year as compared to once per year as currently recommended decrease the risk they have for bleeding due to portal hypertension over three years.\n3. Is there a blood test that can tell us which individuals will experience worsening liver fibrosis before this happens.\n\nParticipants will:\n\nBe screened for schistosomiasis using a urine test If participants have schistosomiasis they will undergo other screening procedures including a liver ultrasound, blood tests, and a physical exam if they have both schistosomiasis and liver (fibrosis) they will be invited to participate in the trial\n\nIf they are in the trial they will:\n\nTake the drug praziquantel once per year or three times per year based on randomization for three years Have a liver ultrasound and blood samples for markers of liver fibrosis once per year Provide a urine sample to test for schistosomiasis each year",[94,95,28,96],"Schistosomiasis","Schistosoma Mansoni","Portal Hypertension",[98,99,100,101,102],"schistosomiasis","schistosome mansoni","hepatic fibrosis","liver fibrosis","portal hypertension","2026-08-07",{"date":69,"type":33},{"date":106,"type":21},"2026-11",{"date":108,"type":21},"2029-11",{"name":110,"class":76},"Rhode Island Hospital",{"id":112,"slug":113,"hasResults":12,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":119,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":120,"targetDuration":4,"studyType":22,"phases":122,"briefSummary":124,"conditions":125,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":138},"100544898","phase-4-fibrosis-lessens-after-metabolic-surgery-100544898","NCT06374875","Fibrosis Lessens After Metabolic Surgery","A Prospective Multicenter International Randomized Controlled Trial Comparing Surgical and Medical Therapies in the Treatment of Advanced Metabolic Dysfunction Associated Steatohepatitis","FLAMES","Inclusion Criteria\n\nEntry into the study would require that the patient:\n\n1. Is a candidate for general anesthesia\n2. Is eligible for metabolic surgery (RYGB or SG) based on the ASMBS\u002FIFSO 2022 guidelines\n3. Has insurance coverage for metabolic surgery (the requirements may vary in each country)\n4. Is ≥18 and ≤75 years old at the time of signing the informed consent\n5. Has a BMI ≥35 and ≤70 kg\u002Fm2 at the time of first study visit\n6. FIB-4 ≥ 1.3\n7. At least one of the following 5 criteria suggesting presence of advanced fibrosis:\n\n   * LSM ≥ 12 kPa by VCTE using FibroScan®\n   * LSM ≥ 12 kPa by SWE\n   * LSM ≥ 1.7 m\u002Fs by ARFI\n   * LSM ≥ 3.63 kPa MRE\n   * ELF score ≥ 9.8\n8. Patients with and without T2DM are eligible for the study. Patients with T2DM should have been on a stable dose of anti-diabetic medication (including insulin but not semaglutide or tirzepatide or liraglutide) for at least 3 months prior to entry, with glycated hemoglobin (HbA1c) ≤12%.\n9. Self-reported stable weight in 6 months before the first study visit (no weight loss \\>10% within 6 months prior to the first study visit)\n\n   a. In patients with a historical noninvasive tests or liver biopsy, weight loss of no more than 10% is allowed from 6 months prior to the historical tests until the first study visit\n10. Has the ability and willingness to participate in the study, provide informed consent, and agree to any of the arms involved in the study\n11. Can understand the options and comply with the requirements of each arm, including one liver biopsy performed during the screening period (if no adequate biopsy within 12 months before screening is available) and one liver biopsy after 2-years\n12. Has a negative urine pregnancy test at the first and at the randomization visits for women of childbearing potential.\n13. Women of childbearing age must agree to use reliable method of contraception for 2 years\n\n8.2 Exclusion Criteria\n\nPatients who meet the following criteria will be excluded from the study:\n\n1. Known history of other chronic liver diseases (drug induced, viral hepatitis, autoimmune, and genetic):\n\n   * Hepatitis B as detected by presence of hepatitis B surface antigen (HBsAg)\n   * Hepatitis C as detected by presence of hepatitis C virus (HCV) RNA (in case the screening test for hepatitis C is positive, the confirmative test is decisive)\n   * Autoimmune liver disease as diagnosed by antibodies or compatible liver histology\n   * Primary biliary cirrhosis as defined by the presence of at least 2 criteria (elevated alkaline phosphatase, presence of anti-mitochondrial antibody, and histologic evidence of nonsuppurative destructive cholangitis and destruction of interlobular bile ducts)\n   * Primary sclerosing cholangitis\n   * Wilson's disease as diagnosed by low ceruloplasmin or compatible liver histology\n   * Alpha-1-antitrypsin deficiency as diagnosed by alpha1-antitrypsin level or liver histology\n   * Hemochromatosis as diagnosed by HFE mutations (C282Y, H63D), ferritin and transferrin saturation levels, or presence of 3+ or 4+ stainable iron on liver biopsy\n   * Drug-induced liver disease diagnosed by medical history\n   * Known bile duct obstruction\n   * Suspected or proven liver cancer\n2. Weight change \\>10% within 6 months prior to the first study visit or prior to the historical liver biopsy\n3. Treatment with semaglutide, tirzepatide, or liraglutide (for obesity or for T2DM) \\\u003C90 days before the first study visit.\n\n   • However, patients are allowed to participate if they have been on a low dose (or are on older generation GLP-1 agonists) and have lost less than 10% of their body weight since starting the medication.\n4. Type 1 diabetes or autoimmune diabetes\n5. Known cases of human immunodeficiency virus infection\n6. Prior bariatric and metabolic surgery of any kind\n\n   • Reversed procedures such as gastric band or intragastric balloon that have been removed at least 3 months prior to the first study visit are allowed.\n7. Prior complex foregut surgery including any esophageal and gastric surgeries, anti-reflux procedures, biliary diversion, and complex trauma surgery\n8. Any surgery requiring general anesthesia within 1 month prior to signing the consent\n9. History of solid organ transplant\n10. Severe pulmonary disease defined as FEV1 \\\u003C 50% of predicted value\n11. Significant cardiac or atherosclerotic disease (planned to undergo cardiac, coronary, carotid, or peripheral artery revascularization procedures in the next 12 months)\n12. Severe uncompensated cardiopulmonary disease leading to American Society of Anesthesiologists Class IV or V\n13. Classified as New York Heart Association Class IV\n14. Left ventricular ejection fraction \\\u003C25% at the time of screening\n15. Myocardial infarction, unstable angina, stroke, heart surgery, coronary stent placement in the past 6 months\n16. Chronic renal insufficiency with eGFR below 30 mL\u002Fmin\u002F1.73 m2, or being on dialysis\n17. Presence of large hiatal hernia (\\>7 cm)\n18. Presence of Crohn's disease\n19. Psychiatric disorders including (but not limited to) dementia, active psychosis, severe depression requiring 3 or more medications, history of suicide attempts, active alcohol, or substance abuse within the previous 12 months that in the opinion of the investigators could disqualify the patient from metabolic surgery\n20. Pregnancy, the intention of becoming pregnant, or not using adequate contraceptive measures\n21. Breastfeeding\n22. Diagnosis of malignancy within the preceding 3 years (except squamous cell and basal cell cancer of the skin)\n23. Anemia defined as hemoglobin less than 9 g\u002FdL\n24. On therapeutic dose of anticoagulants such as warfarin or direct oral anticoagulants (DOACs)\n25. Known history of clotting disorders, including pulmonary embolus and deep vein thrombosis\n26. Clinical judgment that life expectancy is less than 3 years\n27. Use of investigational therapy within 3 months prior to signing the consent\n28. History of pancreatic carcinoma\n29. Acute pancreatitis \\\u003C 180 days before screening\n30. History or presence of chronic pancreatitis\n31. Presence of concerning thyroid nodule\n32. Uncontrolled thyroid disease: thyroid stimulating hormone (TSH) \\> 6.0 mIU\u002FL or \\\u003C 0.1 mIU\u002FL before the first study visit\n\n    * Patients receiving treatment for hypothyroidism can be included if their thyroid hormone replacement dose has been stable for at least 3 months.\n    * Patients whose TSH is outside the rang but they have normal levels of thyroid hormones can be included.\n33. A personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)\n34. Evidence or history of ascites or spontaneous bacterial peritonitis that require(d) treatment\n\n    • Trace ascites identified only by an abdominal imaging without other evidence of clinically significant portal hypertension and esophageal varices is not an exclusion criterion.\n35. Evidence or history of hepatic encephalopathy\n36. Evidence or history of variceal bleeding\n37. Evidence or history of portosplenic vein thrombosis\n38. Current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to the first study visit.\n\n    • Defined as more than 14 units\u002Fweek for females (\\>1 drink per day) and more than 21 units\u002Fweek for males (\\>2 drinks per day) on average, where one unit of alcohol is equivalent to a 12-oz beer, 4-ounce glass of wine, or 1-ounce shot of hard liquor.\n39. Treatment with medications (for more than 14 consecutive days) with known effect on liver steatosis (e.g., treatment with systemic corticosteroids \\[oral or intravenous\\], methotrexate, tamoxifen, valproic acid, amiodarone, or tetracycline) in the 3 months prior to the first study visit (or historical liver biopsy).\n40. ALT or AST or Alkaline phosphatase \\>200 U\u002FL\n41. Recurrent major hypoglycemia or hypoglycemic unawareness\n42. Inability to safely obtain a liver biopsy\n43. Any condition or major illness that, in the investigator's judgment, places the subject at undue risk by participating in the study\n44. Unable to understand the risks, benefits, and compliance requirements of study\n45. Lack capacity to give informed consent\n46. Plans to move outside the primary location of study (country) within the next 24 months\n47. Known or suspected allergy to semaglutide, tirzepatide, liraglutide, excipients, or related products\n48. Previous participation in this trial and got randomized to one of the study groups but did not proceed.\n49. Hospitalization due to COVID-19 within 2 months prior to screening.\n50. Platelet count \\\u003C80,000\n51. International Normalized Ratio (INR) \\>1.7\n52. Child-Pugh score B or C\n53. MELD score ≥15\n54. Upper endoscopy showing gastroesophageal varices\n55. Upper endoscopy showing more than mild portal hypertensive gastropathy\n56. Liver vascular ultrasound (duplex ultrasonography) showing significant portal hypertension characterized by dilated portal vein (\\>13 mm), biphasic or reverse flow in the portal vein, enlarged paraumbilical veins, splenorenal collaterals, or dilated left and short gastric veins.\n\n    Note: Negative findings on upper endoscopy and liver duplex ultrasound (done within one year of the first study visit for both tests) are necessary to establish eligibility for the FLAMES.\n    * Ruling out clinically significant portal hypertension is particularly important in patients with a liver stiffness ≥20 kPa or with a platelet count \\\u003C150,000 per μL or with a (historical) liver biopsy showing cirrhosis.\n    * A subset of patients without having upper endoscopy and liver duplex ultrasound can be eligible for enrollment if their:\n\n      * liver stiffness (by transient elastography using FibroScan®) is between 12 and 15 kPa and their platelet count is \\>150,000 per μL, or\n      * a (historical) liver biopsy showing absence of cirrhosis, or\n      * a (historical) HVPG \\\u003C 5 mmHg\n57. Cross-sectional abdominal imaging (if available historically) indicating presence of large portosystemic collaterals or ascites\n\n    • Splenomegaly alone (in the absence of other radiological and laboratory findings) is not considered to be a sign of clinically significant portal hypertension and is not an exclusion criterion.\n58. HVPG ≥ 12 mmHg (if available historically or if measured at the time of de novo liver biopsy)\n59. Liver biopsy characteristics:\n\n    * F0 in de novo biopsy; Enrollment cap of 20% for F1 in de novo biopsy.\n    * F0 and F1 in historical liver biopsy\n    * Absence of all three components of MASH (steatosis, hepatocyte ballooning, and lobular inflammation) in patients with F1, F2, and F3\n    * Absence of steatosis (\\\u003C5%) in patients with F4\n    * Diagnosis other than MASH",true,{"count":121,"type":21},120,[123],"PHASE4","Metabolic dysfunction-associated steatotic liver disease (MASLD), formerly known as non-alcoholic fatty liver disease (NAFLD), a major global public health concern, is commonly associated with obesity, diabetes, and dyslipidemia. MASLD is currently the most common cause of chronic liver disease affecting about 80% of people with obesity, ranging from simple fat deposits in the liver to Metabolic Dysfunction-Associated Steatohepatitis (MASH), cellular injury, advanced fibrosis, cirrhosis, or hepatocellular carcinoma. Patients with MASH are also at risk for cardiovascular disease and mortality. There is no universally approved medication for MASH. Weight loss remains the cornerstone of MASH treatment.\n\nPatients meeting the inclusion and exclusion criteria and who give informed consent will be enrolled in the trial and undergo the baseline liver biopsy (if none available). Approximately 120 patients with MASH and liver fibrosis (F1-F4 in baseline liver biopsy) will be randomized in a 1:1 ratio to metabolic surgery or medical treatment (incretin-based therapies ± other medical therapies for MASH) and followed for 2 years at which time a repeat liver biopsy will be performed for the assessment of the primary end point.",[126,127,58,28,128],"Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD)","Non-Alcoholic Fatty Liver Disease","Obesity","2026-07-29",{"date":131,"type":33},"2026-07-31",{"date":133,"type":33},"2024-07-11",{"date":135,"type":21},"2029-12-31",{"name":137,"class":76},"The Cleveland Clinic",22,{"id":140,"slug":141,"hasResults":12,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":145,"eligibilityCriteria":146,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":147,"targetDuration":4,"studyType":22,"phases":149,"briefSummary":150,"conditions":151,"keywords":153,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":162},"100638473","phase-2-study-of-azd2389-safety-tolerability-and-pharmacodynamics-in-adults-with-steatotic-liver-disease-and-advanced-fibrosis-100638473","NCT07610837","Study of AZD2389 Safety, Tolerability, and Pharmacodynamics in Adults With Steatotic Liver Disease and Advanced Fibrosis","A Phase IIa, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of AZD2389 in Adult Participants With Steatotic Liver Disease and Advanced Fibrosis (BRAVO)","BRAVO","Key Inclusion Criteria:\n\n* Males\u002Ffemales aged 18 or over\n* A diagnosis of SLD with advanced fibrosis\n* No significant change in weight over the last 6 months\n* Contraceptive us by participants or participants partners\n* Capable of giving informed consent\n* Judged by the investigator to be suitable for study\n\nKey Exclusion Criteria:\n\n* Portal hypertension (LSM \\>25 kPa or 20-25 kPa with platelets \\\u003C150×10⁹\u002FL), decompensated liver disease, Child-Pugh \\>A6, MELD \\>12, other chronic liver diseases, prior\u002Fplanned liver transplant, or malignant liver tumors.\n* Positive viral infections, including HIV or hepatitis B, or hepatitis C unless HCV RNA-negative ≥12 weeks after treatment.\n* Alcohol intake above protocol thresholds, or positive screen for drugs of abuse.\n* Significant metabolic, cardiovascular, or GI disorders, including T1DM or insulin-treated T2DM, uncontrolled hypertension, recent major cardiac\u002Fcerebrovascular events, severe heart failure, serious arrhythmias, significant pancreatic disease, or major GI surgery.\n* History of psychosis, bipolar disorder, recent major depression, or suicide attempt\u002Fideation within 1 year.\n* Bleeding risk or wound-healing concerns, including coagulation disorders, major bleeding history, active wounds or recent major surgery, or severe dermatologic immune conditions.\n* Prohibited medications or hypersensitivities, including moderate\u002Fstrong CYP3A4 or BCRP\u002FOAT3 inhibitors\u002Finducers, anticoagulants\u002Fantiplatelets (except aspirin ≤81 mg\u002Fday), or hypersensitivity to DPP4 inhibitors.\n* Other protocol-defined exclusions, including significant abnormal labs (e.g., worsening ALT\u002FAST), recent participation in another IMP study, or investigator judgment of unsuitability.",{"count":148,"type":21},104,[91],"The purpose of this study is to evaluate the safety, tolerability, and pharmacodynamic effects of AZD2389 in adult participants with steatotic liver disease (SLD) and advanced fibrosis.",[28,152],"Hepatic Cirrhosis",[28,152],"2026-07-28",{"date":129,"type":33},{"date":157,"type":33},"2026-05-07",{"date":159,"type":21},"2027-07-07",{"name":161,"class":40},"AstraZeneca",20,{"id":164,"slug":165,"hasResults":12,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":4,"eligibilityCriteria":169,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":170,"targetDuration":4,"studyType":172,"phases":4,"briefSummary":173,"conditions":174,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":4},"100647989","wearable-patch-ultrasound-probe-for-diagnosis-of-liver-stiffness-100647989","NCT07716384","Wearable Patch Ultrasound Probe for Diagnosis of Liver Stiffness","Diagnostic Accuracy of a Wearable Patch-Type Ultrasound Probe for Detecting Liver Fibrosis and Cirrhosis: A Prospective Cross-Sectional Study","Inclusion Criteria:\n\n* Confirmed or suspected chronic liver disease (including but not limited to chronic viral hepatitis, non-alcoholic fatty liver disease, and alcohol-related liver disease)\n* Scheduled to undergo, or have recently undergone, transient elastography (FibroScan) as part of routine clinical care\n* Age ≥ 18 years\n* Willing and able to provide signed informed consent\n\nExclusion Criteria:\n\n* Ascites (may interfere with liver stiffness measurement by either device) Body mass index (BMI) ≥ 35 kg\u002Fm² (may reduce measurement reliability of transient elastography)\n* Acute hepatitis or acute-on-chronic liver failure at the time of enrollment\n* History of liver transplantation\n* Hepatocellular carcinoma or other space-occupying liver lesions\n* Pregnant women\n* Skin lesions, infection, or scarring at the intended probe application site (right lobe of the liver, intercostal space)\n* Unable to cooperate with the measurement procedure (e.g., severe cognitive impairment)",{"count":171,"type":21},150,"OBSERVATIONAL","Liver stiffness measurement is a key non-invasive tool for assessing liver fibrosis and cirrhosis in patients with chronic liver disease. Transient elastography (FibroScan) is currently the most widely used non-invasive reference standard, but it requires a dedicated device and trained operator, which may limit its accessibility in some clinical settings. This study aims to evaluate the diagnostic accuracy of a novel wearable patch-type ultrasound probe for detecting significant liver fibrosis and cirrhosis, using FibroScan as the reference standard. Patients with chronic liver disease will undergo simultaneous liver stiffness measurement using both the wearable patch ultrasound probe and FibroScan. The diagnostic performance of the patch probe, including sensitivity, specificity, and area under the receiver operating characteristic curve (AUC), will be evaluated against fibrosis staging determined by FibroScan, along with the correlation and agreement between the two measurement methods.",[28,175,176,177],"Liver Cirrhosis","NAFLD (Nonalcoholic Fatty Liver Disease)","HEPATITIS B CHRONIC","2026-07-20",{"date":180,"type":33},"2026-07-21",{"date":182,"type":21},"2026-10-01",{"date":184,"type":21},"2030-10-01",{"name":186,"class":76},"Second Affiliated Hospital of Xi'an Jiaotong University",{"id":188,"slug":189,"hasResults":12,"nctId":190,"briefTitle":191,"officialTitle":191,"acronym":192,"eligibilityCriteria":193,"healthyVolunteers":12,"sex":17,"minAge":87,"maxAge":194,"enrollmentInfo":195,"targetDuration":4,"studyType":22,"phases":197,"briefSummary":198,"conditions":199,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":212},"100492966","screening-in-primary-care-of-advanced-liver-fibrosis-in-nafld-andor-alcoholic-patients-100492966","NCT05699018","Screening in Primary Care of Advanced Liver Fibrosis in NAFLD and\u002For Alcoholic Patients","SOPRANO","Inclusion Criteria:\n\n* NAFLD and\u002For ALD patient defined by at least 1 of the following criteria:\n\n  * Excessive alcohol consumption: higher than 210 g \u002F week (men), or 140 g \u002F week (women)\n  * Type 2 diabetes\n  * at least 2 metabolic factors among BMI higher than or equal to 25 kg \u002F m 2; Elevated blood pressure (antihypertensive drug, or systolic blood pressure higher than or equal to 130mmHg, or diastolic blood pressure higher than or equal to 85mmHg), Dyslipidemia (lipid-lowering drug, or HDL cholesterol lower to 40mg\u002Fdl (men) \u002F 50mg\u002Fdl (women), or triglycerides higher than or equal to150mg\u002Fdl); Hyperferritinemia (higher than upper limit of normal from the laboratory)\n  * Bright liver at ultrasonography without steatosis-inducing drug(systemic corticosteroids, tamoxifen, amiodarone, methotrexate)\n\nFollowing a protocol amendment, the 3 last investigating primary care centres will include NAFLD and\u002For ALD patients according to these updated criteria:\n\n* Excessive alcohol consumption: \\>210 g\u002Fweek in men or \\>140 g\u002Fweek in women,\n* AND\u002FOR type 2 diabetes treated with insulin and\u002For at least two other anti-diabetic treatments,\n* AND with the following stratification:\n\n  30% with excessive alcohol consumption 65% with type 2 diabetes treated with insulin and\u002For at least two other anti-diabetic treatments 5% with both conditions (excessive alcohol consumption, AND type 2 diabetes treated with insulin and\u002For at least two other anti-diabetic treatments)\n* Patient's agreement to have a blood sample collected in a local laboratory participating in the study\n* Subjects covered by or having the rights to medical care assurance\n* Written informed consent obtained from subject\n\nExclusion Criteria:\n\n* Already ongoing specialized follow-up for a chronic liver disease\n* Altered health status with poor short-term prognosis, not compatible with a screening procedure\n* Decompensated cirrhosis (hepatic encephalopathy, jaundice, ascites, variceal bleeding, hepatorenal syndrome)\n* Acute infection\n* Pregnancy, breastfeeding\n* Persons in detention by judicial or administrative decision\n* Person admitted to a health or social establishment for purposes other than research\n* Person subject to a legal protection measure\n* Person unable to express consent","80 Years",{"count":196,"type":21},1788,[54],"The primary objective of the SOPRANO study is to compare two blood fibrosis tests, the eLIFT and the FibroMeter, for the screening of advanced liver fibrosis in patients with NAFLD and\u002For ALD from primary care centers.",[200,201,28],"Non-alcoholic Fatty Liver Disease (NAFLD)","Alcoholic Liver Disease (ALD)","2026-06-26",{"date":204,"type":33},"2026-06-30",{"date":206,"type":33},"2023-03-13",{"date":208,"type":21},"2026-09-12",{"name":210,"class":211},"University Hospital, Angers","OTHER_GOV",13,{"id":214,"slug":215,"hasResults":12,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":22,"phases":222,"briefSummary":223,"conditions":224,"keywords":241,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":262},"100526751","effect-of-endoscopic-sleeve-gastroplasty-in-patients-with-obesity-and-mash-a-randomized-controlled-trial-100526751","NCT06138821","Effect of Endoscopic Sleeve Gastroplasty in Patients With Obesity and MASH: A Randomized Controlled Trial","Effect of Endoscopic Sleeve Gastroplasty on Patients With Obesity and Concomitant Metabolic Dysfunction-Associated Steatohepatitis (MASH): A Multicenter, Open-label, Randomized Controlled Trial","Inclusion Criteria:\n\n1. Age ≥ 18 (male or female)\n2. BMI ≥30 kg\u002Fm2 or ≥27 kg\u002Fm2 with at least one obesity-related comorbidity\n3. Self-reported stable weight (no weight change \\>5%) for 6 months prior to the first study visit\n4. Willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing laboratory\u002Fimaging\u002Fadditional tests, and completing diet counseling\n5. Willingness to NOT start a new anti-obesity medication for the following 12 months\n6. Residing within a reasonable distance from the investigator's office and able to travel to the investigator to complete routine follow-up visits\n7. Ability to give informed consent\n8. Women of childbearing potential (i.e., not post-menopausal, nor surgically sterilized) must agree to use adequate birth control methods\n\nExclusion Criteria:\n\n1. Known history of other chronic liver diseases (viral hepatitis, autoimmune hepatitis, drug-induced hepatitis, and genetic)\n2. Treatment with vitamin E (at doses ≥800 IU\u002Fday), pioglitazone, obeticholic acid, or resmetirom \\\u003C90 days before the first study visit\n3. History of foregut or gastrointestinal (GI) surgery (except uncomplicated fundoplication, cholecystectomy or appendectomy)\n4. Prior bariatric surgery\n5. Prior endoscopic sleeve gastroplasty\n6. Any inflammatory disease of the GI tract, including severe (LA Grade C or D) esophagitis, Barrett's esophagus with dysplasia, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn's disease\n7. Potential upper gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresias or stenoses\n8. Severe gastroesophageal reflux disease (GERD)\n9. A structural abnormality in the esophagus or pharynx, such as a stricture or diverticulum, that could impede passage of the endoscope.\n10. Achalasia or any other severe esophageal motility disorder\n11. Chronic abdominal pain\n12. Gastroparesis or intractable constipation\n13. Hepatic insufficiency or cirrhosis\n14. Severe coagulopathy\n15. Insulin-dependent diabetes (either type 1 or type 2) or a significant likelihood of requiring insulin treatment in the following 12 months or HgbA1C ≥ 12%\n16. Patients on an anti-platelet agent, anticoagulant agent or chronic\u002Froutine use of NSAIDs\n17. Patients on corticosteroids, immunosuppressants, or narcotics\n18. Patients on an anti-seizure or anti-arrhythmic medication\n19. Patients who are pregnant or breastfeeding\n20. Excessive alcohol consumption (\\>20 g per day for women; \\>30 g per day for men)\n21. Active smoking\n22. History of poorly controlled hypertension, coronary artery disease, congestive heart failure, cardiac arrhythmia\n23. History of respiratory diseases such as chronic obstructive pulmonary disease (COPD) requiring steroids, pneumonia, or cancer\n24. History of autoimmune connective tissue disorder such as lupus, scleroderma or immunocompromised disease\n25. History of active malignancy\n26. History of genetic or hormonal causes for obesity, such as Prader Willi syndrome\n27. History of endocrine disorders affecting weight, such as uncontrolled hypothyroidism\n28. Eating disorders, including night eating syndrome, bulimia, binge eating disorder or compulsive overeating\n29. Active psychological issues preventing participation in a lifestyle modification program as determined by a psychologist",{"count":221,"type":21},132,[54],"Metabolic dysfunction-associated steatotic liver disease (MASLD) is the most common chronic liver disease globally. While weight loss through lifestyle modification is the standard treatment, most patients regain weight limiting ultimate improvement in liver disease. On the other end of the spectrum, bariatric surgery has shown promise in the treatment of MASLD\u002Fmetabolic dysfunction-associated steatohepatitis (MASH) due to its efficacy in inducing weight loss. Nevertheless, its adoption has been hindered by the perceived invasiveness of surgery.\n\nOver the past decade, endoscopic sleeve gastroplasty (ESG) has gained recognition as a promising minimally-invasive approach to weight loss. The procedure involves utilizing a Food and Drug Administration (FDA)-authorized endoscopic suturing device to reduce the gastric volume by 70%. Studies reveal that ESG is associated with approximately 18.2% weight loss at one year after the procedure, with sustained results for at least 10 years. Nevertheless, the effect of ESG on MASH remains unknown.\n\nIn this study, the investigators will compare ESG + lifestyle modification versus lifestyle modification alone in treating histologic MASH. The study will randomize patients to one of two different treatment options: ESG + lifestyle modification or lifestyle modification alone.",[128,225,28,226,227,228,229,230,231,232,233,234,235,236,237,238,127,239,240],"Liver Diseases","Liver Fat","Metabolic Dysfunction-Associated Steatotic Liver Disease","Metabolic Dysfunction-Associated Steatohepatitis","MASLD","MASH","Weight Loss","Insulin Resistance","Insulin Sensitivity","Insulin Sensitivity\u002FResistance","Metabolic Disease","Diabetes","Diabetes Mellitus, Type 2","NASH With Fibrosis","Non Alcoholic Fatty Liver","Non-alcoholic Steatohepatitis",[242,243,244,245,246,247,248,249,250,57,58,251,252],"Gut Hormones","Endoscopic Bariatric and Metabolic Therapy (EBMT)","Intragastric Balloon (IGB)","Endoscopic Suturing","Endoscopic Sleeve Gastroplasty (ESG)","Weight Management","Endoscopic Gastric Remodeling (EGR)","Endoscopic Bariatric Therapy (EBT)","Fatty Liver","Non-Alcoholic Fatty Liver Disease (NAFLD)","Non-Alcoholic Steatohepatitis (NASH)","2026-06-23",{"date":255,"type":33},"2026-06-25",{"date":257,"type":33},"2025-06-24",{"date":259,"type":21},"2028-06",{"name":261,"class":76},"Pichamol Jirapinyo, MD, MPH",2,{"id":264,"slug":265,"hasResults":12,"nctId":266,"briefTitle":267,"officialTitle":268,"acronym":269,"eligibilityCriteria":270,"healthyVolunteers":12,"sex":17,"minAge":271,"maxAge":50,"enrollmentInfo":272,"targetDuration":274,"studyType":172,"phases":4,"briefSummary":275,"conditions":276,"keywords":280,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":290,"lastUpdatePostDateStruct":291,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":77},"100641243","automated-passive-case-finding-for-advanced-liver-fibrosis-in-masld-the-liverseek-programme-100641243","NCT07658755","Automated Passive Case-Finding for Advanced Liver Fibrosis in MASLD: The LiverSeek Programme","Towards Universal Screening for Metabolic Dysfunction-Associated Liver Fibrosis in Primary Care: Evaluation of a Single-Step, Laboratory Informatión System-Driven Automated Case-Finding Strategy (LiverSeek)","LiverSeek","Inclusion Criteria:\n\n1. Age between 50 and 75 years (inclusive)\n2. Routine blood test processed in the Clinical Biochemistry Laboratory of Hospital General Universitario Gregorio Marañón, ordered by a primary care physician in one of the 11 affiliated SERMAS primary care centres\n3. Presence of at least one of the following metabolic risk factor combinations:\n\n   * ALT above the upper limit of normal AND HbA1c ≥6.5%\n   * ALT above the upper limit of normal AND BMI \\>30 kg\u002Fm²\n   * BMI \\>30 kg\u002Fm² AND HbA1c ≥6.5%\n\nExclusion Criteria:\n\n1. Age \\\u003C50 years or \\>75 years\n2. Known pre-existing liver disease (significant or advanced fibrosis, cirrhosis, hepatocellular carcinoma, prior liver transplantation)\n3. Prior fibrosis assessment within the preceding 12 months.","50 Years",{"count":273,"type":21},3000,"24 Months","LiverSeek is a fully automated, passive case-finding programme for advanced liver fibrosis associated with metabolic dysfunction-associated steatotic liver disease (MASLD) in primary care. The programme operates through the Laboratory Information System (LIS; Modulab\u002FBiwer Analytics) of the Clinical Biochemistry Laboratory at Hospital General Universitario Gregorio Marañón (HGUGM), covering approximately 350,000 inhabitants across 11 peri-urban primary care centres affiliated to SERMAS (Servicio Madrileño de Salud) in Madrid, Spain.\n\nWhen a high-risk patient (age 50-75 years with ≥1 of: ALT above ULN + HbA1c ≥6.5%; ALT above ULN + BMI \\>30; BMI \\>30 + HbA1c ≥6.5%) undergoes a routine blood test in primary care, the LIS automatically calculates FIB-4. If FIB-4 \\>1.30, the system reflexively orders ELF and MASEF from the same serum sample, without any action required from the primary care clinician. Patients with a positive second-step NIT (ELF ≥9.8 or MASEF ≥0.33) receive an automatic alert directing them to the Hepatology Advanced Practice Nurse for VCTE (FibroScan) and clinical evaluation.\n\nThe primary objective is to evaluate the prevalence of hepatic fibrosis in the high-risk population using this single-step automated strategy. Secondary objectives include head-to-head diagnostic comparison of FIB-4+ELF vs FIB-4+MASEF vs FIB-4+FAST for histologically-confirmed endpoints (significant fibrosis ≥F2, advanced fibrosis ≥F3, at-risk MASH), evaluation of the Liver Risk Score, and a health-economic analysis. A sub-study evaluates a nurse-led structured lifestyle intervention in NIT-positive patients.",[227,28,277,278,128,279],"Non-alcoholic Fatty Liver Disease NAFLD","Type 2 Diabetes Mellitus","Obesity Type 2 Diabetes Mellitus",[229,281,282,101,283,284,285,286,287,288,289],"MAFLD","NAFLD","FIB-4","ELF","MASEF","screening","passive screening","advanced practice nurse","lifestyle intervention","2026-06-14",{"date":292,"type":33},"2026-06-22",{"date":294,"type":33},"2024-10-01",{"date":296,"type":21},"2027-09-01",{"name":298,"class":76},"Hospital General Universitario Gregorio Marañon",{"id":300,"slug":301,"hasResults":12,"nctId":302,"briefTitle":303,"officialTitle":304,"acronym":305,"eligibilityCriteria":306,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":194,"enrollmentInfo":307,"targetDuration":309,"studyType":172,"phases":4,"briefSummary":310,"conditions":311,"keywords":313,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":77},"100639234","correlation-of-eus-swq-and-liver-fibrosis-pathology-in-chronic-liver-disease-100639234","NCT07588854","Correlation Of EUS-SWQ And Liver Fibrosis Pathology In Chronic Liver Disease","EU-ME3 Endoscopic Ultrasound Shear Wave Quantification (EUS-SWQ) for Evaluating Liver Fibrosis and Histopathology in Patients With Chronic Liver Disease","EUS-SWQ-202601","Inclusion Criteria:\n\n1. Age ≥ 18 years and ≤ 80 years.\n2. Patients with clinical indications scheduled to undergo liver biopsy (EUS-guided) for the evaluation of liver lesions. Chronic liver disease meeting criteria for biopsy includes:Hepatitis B；Fatty liver disease；Autoimmune hepatitis；Other chronic liver diseases of unknown etiology that would benefit from liver biopsy\n3. Planned to undergo EUS-SWQ and FibroScan examinations prior to biopsy.\n4. Willing to provide and sign written informed consent.\n\nExclusion Criteria:\n\n1. Patients unable to tolerate endoscopic procedures.\n2. Patients with contraindications to endoscopy or anesthesia.\n3. Coagulopathy (platelet count \\\u003C 50×10⁹\u002FL, PT \\> upper limit of normal by 3 seconds).\n4. Patients with severe underlying diseases of the respiratory, cardiovascular, cerebrovascular, digestive, or hematologic systems, as well as those with psychiatric disorders.\n5. Patients with surgically altered anatomy that precludes adequate EUS imaging of the hepatic parenchyma.\n6. Patients with imaging findings suggestive of malignant liver tumors.\n7. Pregnant or lactating women.\n8. Patients with decompensated cirrhosis (gastrointestinal bleeding, ascites, encephalopathy).\n9. Patients who refuse to participate in the clinical study.\n10. Any other conditions deemed inappropriate by the investigator.",{"count":308,"type":21},65,"2 Weeks","The goal of this clinical study is to learn whether the Olympus EU-ME3 endoscopic ultrasound shear wave quantification (EUS-SWQ) function can accurately diagnose and grade liver fibrosis in patients with chronic liver disease. It will also learn about the safety and measurement success rate of EUS-SWQ.\n\nThe main questions it aims to answer are:\n\nHow closely do EUS-SWQ measurements match liver fibrosis stages determined by liver biopsy (the reference standard)? Does EUS-SWQ correlate better with liver biopsy results than FibroScan? How safe is EUS-SWQ and how often can successful measurements be obtained? Researchers will compare EUS-SWQ results with liver biopsy pathology (METAVIR F0-F4) and with FibroScan results to evaluate its diagnostic value.\n\nParticipants will:\n\nBe adults with chronic liver disease who are scheduled to undergo a clinically indicated liver biopsy Undergo an EUS-SWQ examination as part of the study Have their liver stiffness measured by both EUS-SWQ and FibroScan for comparison Be monitored for any discomfort or adverse events related to the procedures A total of 65 participants will take part in this prospective, single-center, post-market clinical study.",[312,28],"Chronic Liver Disease (CLD)",[314,315,316,317,318,319,320],"Chronic liver disease","Liver fibrosis","EUS-SWQ","Endoscopic ultrasound","Liver biopsy","FibroScan","Olympus EU-ME3","2026-05-13",{"date":323,"type":33},"2026-05-15",{"date":325,"type":21},"2026-05",{"date":327,"type":21},"2028-01",{"name":329,"class":76},"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine",{"id":331,"slug":332,"hasResults":12,"nctId":333,"briefTitle":334,"officialTitle":335,"acronym":4,"eligibilityCriteria":336,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":194,"enrollmentInfo":337,"targetDuration":4,"studyType":22,"phases":339,"briefSummary":340,"conditions":341,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":343,"startDateStruct":344,"completionDateStruct":346,"leadSponsor":348,"locationsCount":77},"100640330","sonazoid-ceus-for-early-hcc-surveillance-100640330","NCT07590284","Sonazoid CEUS for Early HCC Surveillance","A Multicenter, Prospective Study of Sonazoid CEUS for Early HCC Surveillance in a High-risk Population","Inclusion Criteria:\n\n1. Cirrhotic patients diagnosed clinically or radiologically due to any etiology (patients with cirrhosis due to congenital fibrosis and patients with cirrhosis due to vascular causes were excluded).\n2. Age 18-80 years old.\n3. Able to receive regular imaging, including US, CEUS, and CECT or CEMRI or EOB-MRI, according to the diagnostic and treatment procedures.\n4. Obtained informed consent from the patient.\n\nExclusion Criteria:\n\n1. Patients with pathologic or enhanced imaging of established HCC who have not undergone curative treatment.\n2. Patients with known hypersensitivity to enhanced imaging contrast agents.\n3. Patients with severe cardiac, pulmonary or renal insufficiency that precludes CECT or CEMRI or EOB-MRI.\n4. Lactating and pregnant women.\n5. Those who are not suitable for enrollment as assessed by the investigator.\n6. Patients with egg or egg-product allergy, or with severe right-to-left cardiac shunt or intrapulmonary shunt.",{"count":338,"type":21},556,[54],"This study is a multicenter, prospective study. In this study, enrolled subjects are cirrhotic patients of any etiology. The US and Sonazoid CEUS monitoring strategy was performed for cirrhotic patients: US and AFP joint with Sonazoid CEUS every 4 to 6 months, and combined CECT\u002FCEMRI every 12 months.",[175,28],"2026-05-11",{"date":323,"type":33},{"date":345,"type":21},"2026-05-30",{"date":347,"type":21},"2029-12-30",{"name":349,"class":76},"Tianjin Third Central Hospital",{"id":351,"slug":352,"hasResults":12,"nctId":353,"briefTitle":354,"officialTitle":354,"acronym":4,"eligibilityCriteria":355,"healthyVolunteers":119,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":356,"targetDuration":358,"studyType":172,"phases":4,"briefSummary":359,"conditions":360,"keywords":363,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":368,"startDateStruct":370,"completionDateStruct":372,"leadSponsor":374,"locationsCount":77},"100613358","single-cell-multiomics-and-spatiotemporal-omics-analyze-the-mechanism-of-liver-degenerative-disease-100613358","NCT07265544","Single-cell Multiomics and Spatiotemporal Omics Analyze the Mechanism of Liver Degenerative Disease","Inclusion Criteria:\n\n1. Voluntarily signed the informed consent form;\n2. No restrictions on age and gender;\n3. Patients diagnosed with hepatic hemangioma or focal nodular hyperplasia of the liver in accordance with the \"Guidelines for the Diagnosis and Treatment of Focal Liver Lesions (2014 Edition)\" and the \"Guidelines for the Diagnosis and Treatment of Hemangiomas and Vascular Malformations (2019 Edition)\";\n4. Patients with hepatic hemangioma, focal nodular hyperplasia of the liver, fatty liver, HBV infection, liver fibrosis, and cirrhosis who clinically require liver surgery or liver biopsy.\n\nExclusion Criteria:\n\n1. Individuals with concurrent infections such as HIV will be excluded.\n2. Patients with coagulation system disorders, such as hemophilia or idiopathic thrombocytopenic purpura, will not be included.\n3. Those with severe underlying diseases that affect the body's immune status will be excluded.\n4. Individuals whom the investigator deems unsuitable for participation in this study will be excluded.",{"count":357,"type":21},240,"7 Days","The purpose of this observational study is to employ single-cell multi-omics and spatial omics technologies to characterize the spatial and immune structures within the livers of patients with fatty liver, hepatic hemangioma, focal nodular hyperplasia, liver fibrosis, cirrhosis, and HBV infection. The primary questions it aims to address are:\n\nInvestigate the mechanisms of liver degenerative changes during the processes of liver aging, fatty liver, HBV infection, liver fibrosis, and cirrhosis.\n\nCharacterize the molecular features and cellular networks at different stages of liver degeneration and identify new targets and mechanisms for the cure of the aforementioned diseases.\n\nThe study will collect peripheral blood and discarded liver tissue from patients with hepatic hemangioma, fatty liver, HBV infection, liver fibrosis, and cirrhosis who are undergoing hepatectomy or liver biopsy.",[361,362,277,28],"Liver Neoplasm","HBV Infection",[364,365,366],"single-cell multi-omics","HBV infection","liver degenerative changes","2026-04-13",{"date":369,"type":33},"2026-04-14",{"date":371,"type":33},"2023-03-01",{"date":373,"type":21},"2027-02-12",{"name":375,"class":76},"Nanfang Hospital, Southern Medical University",{"id":377,"slug":378,"hasResults":12,"nctId":379,"briefTitle":380,"officialTitle":381,"acronym":382,"eligibilityCriteria":383,"healthyVolunteers":119,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":384,"targetDuration":386,"studyType":172,"phases":4,"briefSummary":387,"conditions":388,"keywords":389,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":395,"lastUpdatePostDateStruct":396,"startDateStruct":398,"completionDateStruct":400,"leadSponsor":402,"locationsCount":77},"100633725","samsung-s-viscosity-vs-canon-dispersion-slope-in-steatotic-liver-disease-savid-sld-100633725","NCT07530419","Samsung S-Viscosity vs Canon Dispersion Slope in Steatotic Liver Disease (SAVID-SLD)","Prospective Evaluation of Samsung Medison 2D Shear Wave Elastography Viscoelasticity Parameters in Patients With Steatotic Liver Disease Using Canon Dispersion Slope Imaging as Reference Standard: A Single-Center Non-Interventional Observational Study","SAVID-SLD","Inclusion Criteria:\n\n* \\[Cohort A - Healthy reference\\]\n\n  * Adults ≥18 years old\n  * Currently undergoing living-donor evaluation at SNUH\n  * Donor evaluation confirms (a) hepatic steatosis \\\u003C5% by imaging or biopsy, (b) normal AST\u002FALT, and (c) absence of chronic liver disease (HBV, HCV, autoimmune, cholestatic, etc.)\n  * Provided written informed consent \\[Cohort B + C - Steatotic liver disease\\]\n  * Adults ≥18 years old\n  * Sonographically suspected or confirmed hepatic steatosis on B-mode ultrasound, scheduled for clinical abdominal ultrasound\n  * Serum AST\u002FALT results available within 6 weeks of ultrasound, or scheduled\n  * Provided written informed consent\n\nExclusion Criteria:\n\n* • Significant alcohol intake within the past 2 years (\\>30-60 g\u002Fday for males, \\>20-50 g\u002Fday for females)\n\n  * Diagnosed or strongly suspected chronic liver disease (active HBV\u002FHCV, autoimmune liver disease, cholestatic liver disease, Wilson's disease, hemochromatosis, etc.)\n  * Suspected hepatic failure or decompensated cirrhosis (albumin \\\u003C3.2 g\u002FdL, INR \\>1.3, direct bilirubin \\>1.3 mg\u002FdL)\n  * Ascites, history of variceal bleeding, or acute biliary obstruction rendering stable measurements unfeasible\n  * History of liver malignancy or treatment for liver malignancy\n  * History of liver surgery\n  * Pregnancy or lactation\n  * Inadequate ultrasound image quality due to obesity, bowel gas, or patient inability to cooperate",{"count":385,"type":21},95,"1 Week","Steatotic liver disease (SLD) is one of the most common chronic liver diseases worldwide. Distinguishing simple steatosis from metabolic dysfunction-associated steatohepatitis (MASH) with significant fibrosis is clinically important, but liver biopsy - the current standard - is invasive. Recent ultrasound technology allows noninvasive measurement of tissue viscoelasticity, which has been linked to liver inflammation. Samsung Medison's HERA W12 system (S-Viscosity) and Canon Aplio i800 (Dispersion Slope Imaging) both provide vendor-specific viscoelasticity parameters derived from shear-wave dispersion analysis, but their relationship and agreement have not been compared in SLD patients.\n\nThis prospective single-center observational study will enroll approximately 95-100 participants in three cohorts: (A) 15-20 living-donor candidates as a healthy reference, (B+C) approximately 80 adults with sonographically suspected or confirmed SLD recruited consecutively. SLD participants will be classified post-hoc into low-MASH-risk (Cohort B) and at-risk MASH (Cohort C) subgroups using a multi-parametric stratification combining liver stiffness (LSM), DeepUSFF (deep-learning-based ultrasound fat fraction), and serum AST. All participants will undergo same-day ultrasound examination with both Samsung HERA W12 and Canon Aplio i800. The primary objective is to evaluate the correlation and agreement between Samsung S-Viscosity and Canon Dispersion Slope. Secondary objectives include deriving a normal reference range from the healthy cohort, comparing viscoelasticity parameters across cohorts, and exploring a Modified US-FAST score.",[227,250,28],[390,391,392,65,393,229,230,394],"Shear wave elastography","Viscoelasticity","Dispersion slope","Quantitative ultrasound","S-Viscosity","2026-04-08",{"date":397,"type":33},"2026-04-15",{"date":399,"type":21},"2026-04-10",{"date":401,"type":21},"2027-02-28",{"name":403,"class":76},"Seoul National University Hospital",{"id":405,"slug":406,"hasResults":12,"nctId":407,"briefTitle":408,"officialTitle":409,"acronym":4,"eligibilityCriteria":410,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":411,"enrollmentInfo":412,"targetDuration":414,"studyType":172,"phases":4,"briefSummary":415,"conditions":416,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":418,"startDateStruct":420,"completionDateStruct":422,"leadSponsor":424,"locationsCount":77},"100632456","the-correlation-between-hs-crp-tg-triglycerides-glucose-index-in-nafld-and-liver-fibrosis-100632456","NCT07513922","The Correlation Between hs CRP TG Triglycerides Glucose Index in NAFLD and Liver Fibrosis","Correlation Between hs CRP TG Triglycerides Glucose Index in NAFLD and Liver Fibrosis","Inclusion Criteria:\n\n1. Adults ≥18 years\n2. Available fasting labs: TG, fasting glucose, hs-CRP\n3. Valid liver assessment by VCTE (FibroScan LSM) and CAP or ultrasound-based steatosis assessment\n\nExclusion Criteria:\n\n* 1- Significant alcohol intake (define using your local standard; commonly sex-specific thresholds) 2- Viral hepatitis (HBsAg positive and\u002For HCV RNA positive) 3- Other chronic liver diseases (autoimmune hepatitis, hemochromatosis, Wilson's, etc.) 4- Pregnancy","85 Years",{"count":413,"type":21},96,"1 Year","The Correlation between hs CRP TG triglycerides Glucose index in NAFLD and liver fibrosis",[28],"2026-03-31",{"date":419,"type":33},"2026-04-07",{"date":421,"type":21},"2026-10-02",{"date":423,"type":21},"2027-12-02",{"name":425,"class":76},"Assiut University",{"id":427,"slug":428,"hasResults":12,"nctId":429,"briefTitle":430,"officialTitle":430,"acronym":431,"eligibilityCriteria":432,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":433,"targetDuration":435,"studyType":172,"phases":4,"briefSummary":436,"conditions":437,"keywords":442,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":447,"lastUpdatePostDateStruct":448,"startDateStruct":450,"completionDateStruct":452,"leadSponsor":454,"locationsCount":4},"100629537","prevalence-and-risk-factors-of-metabolic-associated-hepatic-steatosis-in-individuals-living-with-type-1-diabetes-100629537","NCT07475962","Prevalence and Risk Factors of Metabolic-Associated Hepatic Steatosis in Individuals Living With Type 1 Diabetes","STEA-DT1","Inclusion Criteria:\n\n* Individuals ≥ 18 years of age.\n* A clinical diagnosis of type 1 diabetes or Latent Autoimmune Diabetes in Adults (LADA) for at least one year, as per the investigators' clinical judgment (confirmatory C-peptide and antibodies will not be required).\n\nExclusion Criteria:\n\n* Alcohol consumption exceeding 20g per day in women or 30g per day in men.\n* Known chronic liver disease (including viral, drug-induced, Wilson disease, deficit in alpha-1-antirypsin, hemochromatosis, autoimmune hepatitis, etc.).\n* Evidence of cirrhosis based on a result of liver biopsy, or history of portal hypertension presented by ascites, hepatic encephalopathy or varices.\n* History of use of medications known to induce liver steatosis, including corticosteroids, high-dose estrogens, tamoxifen, methotrexate, amiodarone, or tetracycline.\n* Ongoing pregnancy.\n* Life expectancy of less than 5 years, as per investigators' clinical judgment.",{"count":434,"type":21},100,"3 Days","The goal of this observational cross-sectional study is to assess the prevalence and stage of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), specifically liver steatosis and fibrosis in adults aged 18 and older living with type 1 diabetes or Latent Autoimmune Diabetes in Adults (LADA) in Quebec.\n\nThe main questions it aims to answer are:\n\n1. What is the prevalence and severity of liver steatosis and fibrosis among people living with type 1 diabetes in Québec?\n2. Are there patients with type 1 diabetes who have advanced, undiagnosed stages of liver disease that require management but are missed by current standard care practices?\n\nResearchers will compare three participant subgroups based on adiposity (a control group without increased adiposity, an overweight group with increased adiposity, and an obesity group with increased adiposity) to see if the prevalence and severity of hepatic steatosis and fibrosis are highest in the obesity group and lowest in the control group. They will also explore if variables and potential risk factors associated with liver disease differ across these subgroups.\n\nParticipants will attend a single study visit where they will be asked to:\n\n* Provide clinical data through laboratory analyses.\n* Undergo specific clinical procedures.\n* Complete validated questionnaires.",[438,439,440,28,441],"Type 1 Diabetes","Liver Steatoses","MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease","Latent Autoimmune Diabetes in Adult (LADA)",[229,443,315,444,445,446],"Liver steatosis","LADA","Body composition","Type 1 diabetes","2026-03-19",{"date":449,"type":33},"2026-03-23",{"date":451,"type":21},"2026-04-01",{"date":453,"type":21},"2027-05-30",{"name":455,"class":76},"Institut de Recherches Cliniques de Montreal",{"id":457,"slug":458,"hasResults":12,"nctId":459,"briefTitle":460,"officialTitle":461,"acronym":4,"eligibilityCriteria":462,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":463,"targetDuration":4,"studyType":172,"phases":4,"briefSummary":465,"conditions":466,"keywords":467,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":471,"lastUpdatePostDateStruct":472,"startDateStruct":473,"completionDateStruct":475,"leadSponsor":477,"locationsCount":77},"100395438","rapid-breath-hold-quantitative-macromolecular-proton-fraction-imaging-for-liver-fibrosis-100395438","NCT04429100","Rapid Breath-hold Quantitative Macromolecular Proton Fraction Imaging for Liver Fibrosis","Assessment of Fibrosis by Non-invasive Quantitative Imaging of Collagen in the Liver Using Breath-hold MRI With Comparison With MR Elastography and Liver Biopsy","Inclusion Criteria:\n\n1. Patient group\n\n   * patients with histology-proven liver fibrosis, including those with liver fibrosis stage F0, early-stage liver fibrosis (F1-2), and late stage.\n\n   liver fibrosis(F3-4).\n   * patient aged 18 years old and above.\n2. Healthy control group\n\n   * controls aged 18 years old and above.\n\nExclusion Criteria:\n\n* Contraindications to MRI, such as cardiac pacemaker, claustrophobia, pregnancy, metallic implants not suitable for MRI scan.",{"count":464,"type":21},200,"Chronic liver disease is a major health problem worldwide. Liver fibrosis is a key feature in most chronic liver diseases. When identified early, liver fibrosis may be reversible. Currently, liver biopsy is the gold standard for the diagnosis of liver fibrosis. Liver biopsy; however, is invasive. Non-invasive diagnostic tools are increasingly used in clinical practice. However, the existing noninvasive methods still have significant limitations to detect early-stage liver fibrosis.\n\nLiver fibrosis is characterized by excessive deposition of collagen-rich connective tissues in the liver. The macromolecular proton fraction (MPF) is an MRI parameter which characterizes the magnetization transfer (MT) effect in tissues. Quantitative MPF imaging is non-invasive and can be used to measure collagen deposition in the liver due to the strong MT effect of collagen. It has been reported MPF quantification can be used for diagnosis of early-stage liver fibrosis. However, the existing approaches require B1, B0, and T1 map in addition to the imaging data for MPF quantification, which makes it challenging to adopt them for routine clinical use.\n\nThe investigators propose a fast and robust MPF quantification approach. In contrast to the existing methods which rely on saturation radiofrequency pulses for MPF quantification, our approach is based on spin-lock radiofrequency pulses which have minimum Rabi oscillations. The whole imaging data can be acquired within a breath-hold less than 8 seconds. Our approach only needs a B1 map in addition to the imaging data for MPF quantification. The preliminary clinical studies on 3.0T MRI show the measurement using our approach is specific to collagen content and can be used to detect early-stage liver fibrosis. To further confirm the clinical value of the proposed approach, the investigators will investigate the relationship of the collagen content measured using the proposed non-invasive imaging approach and those measured based on morphometry analysis of histology, and determine the diagnostic value of the proposed method for detection of early stage liver fibrosis in a large cohort. The investigators will also perform comparative studies of the proposed method and the state-of-the-art quantitative MPF imaging technique.\n\nThis project will provide a diagnostic technology for early detection of liver fibrosis. The proposed MRI technology also has potential to be used for other clinical purposes.",[28],[468,469,470],"magnetic resonance imaging","quantitative imaging","spin-lock","2026-03-18",{"date":447,"type":33},{"date":474,"type":33},"2020-03-01",{"date":476,"type":21},"2027-12-30",{"name":478,"class":76},"Chinese University of Hong Kong",{"id":480,"slug":481,"hasResults":12,"nctId":482,"briefTitle":483,"officialTitle":483,"acronym":484,"eligibilityCriteria":485,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":486,"targetDuration":4,"studyType":172,"phases":4,"briefSummary":487,"conditions":488,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":489,"lastUpdatePostDateStruct":490,"startDateStruct":492,"completionDateStruct":494,"leadSponsor":496,"locationsCount":262},"100595333","city-hospital-collaboration-for-early-detection-of-liver-fibrosis-in-primary-care-a-secondary-prevention-project-in-the-grenoble-health-area-100595333","NCT07031089","City-Hospital Collaboration for Early Detection of Liver Fibrosis in Primary Care: A Secondary Prevention Project in the Grenoble Health Area","PREFIB","Inclusion Criteria:\n\n* Patients aged 18 years or older\n* Having undergone a Fibroscan® at the CHU de Grenoble-Alpes or CPTS-SEG, requested by a primary care practitioner (general practitioner, non-hospital diabetologist, Asalée nurse), as part of the screening recommendations for liver fibrosis in the case of a FIB4 score \\> 1.3\n* With a result ≥ 8kPa\n* Between January 2023 and January 2026\n\nExclusion Criteria:\n\n* Patients who have expressed their opposition to participating in the study\n* Patients under guardianship or deprived of liberty\n* Patients with a known chronic liver disease who are being monitored at the time of the Fibroscan® procedure",{"count":171,"type":21},"Cirrhosis and hepatocellular carcinoma (HCC) are responsible for 25,000 deaths per year in France. The main causes are excessive alcohol consumption, metabolic steatosis, and hepatitis B and C. Fibrosis, classified from F0 (absence of fibrosis) to F4 (cirrhosis), is the sole determinant of liver-related mortality, particularly from stage F3. The incidence of metabolic steatosis is increasing, associated with a rise in mortality from chronic liver diseases (CLD). CLDs, often asymptomatic, are diagnosed late, reducing patient survival. Recommendations exist for the screening of hepatic fibrosis in at-risk patients (alcohol, diabetes, metabolic syndrome). This screening relies on calculating the FIB-4 score (calculated from widely prescribed variables: AST, ALT, platelets, age), followed by Fibroscan® (a non-invasive test for hepatic fibrosis) if FIB-4 \\> 1.3.\n\nA Fibroscan® result \\\u003C8kPa excludes advanced fibrosis, while a result \\>9.6kPa suggests advanced fibrosis and ≥15kPa indicates cirrhosis. The appropriate care pathway includes a risk reduction program, a specialized consultation for patients with Fibroscan® ≥8kPa, and semi-annual screening for HCC in the case of cirrhosis. Indeed, it has been shown in a French cohort of patients with viral C cirrhosis that adherence to semi-annual screening is associated with better survival.\n\nEligible patients are primarily seen in primary care, and INCA has published a recommendation intended for general practitioners to improve the screening of fibrosis \\[13\\]. However, FIB-4 is poorly known among general practitioners \\[14\\], and access to Fibroscan® remains limited \\[15\\], hindering the implementation of the recommendations. Therefore, a care pathway has been established in the Grenoble area, initiated by Professor Costentin, allowing access to Fibroscan® for patients in primary care, starting from 2022 at the CHU. The objective is to evaluate the completion of the pathway, particularly the management of MCF risk factors and referral to specialized consultation for patients with Fibroscan® ≥8 kPa.",[28],"2026-02-26",{"date":491,"type":33},"2026-03-02",{"date":493,"type":33},"2026-01-14",{"date":495,"type":21},"2029-01-14",{"name":497,"class":76},"University Hospital, Grenoble",{"id":499,"slug":500,"hasResults":12,"nctId":501,"briefTitle":502,"officialTitle":503,"acronym":4,"eligibilityCriteria":504,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":194,"enrollmentInfo":505,"targetDuration":506,"studyType":172,"phases":4,"briefSummary":507,"conditions":508,"keywords":510,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":489,"lastUpdatePostDateStruct":513,"startDateStruct":515,"completionDateStruct":517,"leadSponsor":519,"locationsCount":77},"100575959","mr-elastography-for-assessing-liver-fibrosis-in-chronic-hepatitis-b-100575959","NCT06779058","MR Elastography for Assessing Liver Fibrosis in Chronic Hepatitis B","Retrospective and Prospective Multi-center Clinical Study of Magnetic Resonance Elastography in Evaluating Hepatic Fibrosis in Chronic Viral Hepatitis B","Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Confirmed CHB (laboratory, imaging and clinical tests)\n* MRE within 6 months before and after liver biopsy\n* Treatment-naïve\n* Child-Pugh Grade A (\\\u003C7 points)\n* Written informed consent in prospective follow-up cohort\n\nExclusion Criteria:\n\n* Patients with liver malignant tumor\n* Chronic hepatitis due to other causes (such as alcoholic hepatitis)\n* CHB combined with hepatitis C, hepatitis D, or HIV\n* Patients with biliary tract diseases\n* Contraindications of MRE examination, MRE failure\n* Poor pathological effect",{"count":89,"type":21},"2 Years","How to construct a non-invasive, accurate, and convenient method to evaluate the severity of liver fibrosis (LF) is an important general problem in the management of patients with chronic hepatitis B (CHB). We plan to investigate the ability of magnetic resonance elastography (MRE) to grade fibrosis in chronic hepatitis B and apply to clinical longitudinal follow-up.",[509,28],"Chronic Hepatitis B",[511,65,512],"Magnetic resonance elastography","Antiviral therapy",{"date":514,"type":33},"2026-02-27",{"date":516,"type":33},"2025-01-01",{"date":518,"type":21},"2026-12-01",{"name":520,"class":76},"Shengjing Hospital",{"id":522,"slug":523,"hasResults":12,"nctId":524,"briefTitle":525,"officialTitle":526,"acronym":4,"eligibilityCriteria":527,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":528,"targetDuration":4,"studyType":22,"phases":530,"briefSummary":531,"conditions":532,"keywords":534,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":539,"lastUpdatePostDateStruct":540,"startDateStruct":542,"completionDateStruct":544,"leadSponsor":545,"locationsCount":77},"100479681","phase-2-thyroid-hormone-for-treatment-of-nonalcoholic-steatohepatitis-in-veterans-100479681","NCT05526144","Thyroid Hormone for Treatment of Nonalcoholic Steatohepatitis in Veterans","Low Dose Thyroid Hormone, Mitochondrial Fatty Acid Oxidation, and Treatment of Nonalcoholic Steatohepatitis (NASH)","Inclusion Criteria:\n\n* Men and women (pre- and post-menopausal)\n* Overweight\u002Fobese subjects with body mass index (BMI) at or above 25.9 kg\u002Fm2\n* Alcohol intake \\\u003C 20 grams per day\n* Patients with type 2 diabetes on stable doses of antidiabetic medication for at least 3 months before enrollment\n* Patients who are treated with vitamin E or pioglitazone should be on stable doses for at least 6 months before enrollment\n* Features of metabolic syndrome: 3 or more (central obesity, hypertension, low HDL, high triglycerides, high fasting glucose)\n* Scheduled for a medically indicated, diagnostic liver biopsy\n* Female patients are eligible if they are of reproductive potential and have a negative serum pregnancy test (beta human chorionic gonadotropin), are not breastfeeding, and do not plan to become pregnant during the study and agree to use two highly effective birth control methods during the study OR if they are not of child-bearing potential (i.e., surgically \\[bilateral oophorectomy, hysterectomy, or tubal ligation\\] or naturally sterile \\[\\> 12 consecutive months without menses\\])\n\n  * Highly effective birth control methods include condoms with spermicide, diaphragm with spermicide, hormonal and nonhormonal intrauterine device, hormonal contraception (estrogens stable for at least 3 months), a vasectomized male partner, or sexual abstinence (defined as refraining from heterosexual intercourse), from screening, throughout the study, and for at least 30 days after the last dose of study drug administration\n  * Reliance on abstinence from heterosexual intercourse is acceptable only if it is the patient's habitual practice\n* If a patient is on digitalis and amiodarone, he\u002Fshe is expected to use\u002Fcontinue these medications throughout the treatment period only after consultation with their cardiologist for monitoring and dose adjustments if necessary\n\nExclusion Criteria:\n\n* Other causes of hepatitis including hepatitis B \\& C, autoimmune hepatitis, hemochromatosis, celiac disease, Wilson's disease, alpha-1-antitrypsin deficiency, medication-induced hepatitis\n* Alcohol consumption of 20 g\u002Fd or more\n* Patients with cirrhosis, bilirubin of 1.3 mg\u002FdL or more, and INR of 1.3 or more\n* Evidence of Portal hypertension\n* Pregnancy\n* History of malignant hypertension\n* Uncontrolled hypertension (either treated or untreated) defined as systolic blood pressure \\> 160 mm Hg or a diastolic blood pressure \\> 100 mm Hg at screening\n* New York Heart Association Class III or IV heart failure or known left ventricular ejection fraction \\\u003C 30%\n* Uncontrolled cardiac arrhythmia, including confirmed QT interval corrected using Fridericia's formula (QTcF) \\> 450 msec for males and \\> 470 msec for females at the screening electrocardiogram (ECG) assessment\n* History of myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass graft, or stroke within at least 3 months prior to randomization\n* History of high degree AV block (Mobitz II or complete) in the absence of a pacemaker\n* Patients with uncorrected adrenal insufficiency\n* Patients who are on tricyclic or tetracyclic antidepressants or ketamine, if they are unwilling and\u002For unable to discontinue these medications to allow adequate washout prior to randomization\n* Patients who are on Teduglutide or Midodrine",{"count":529,"type":21},128,[91],"Nonalcoholic steatohepatitis (NASH) is the aggressive form of nonalcoholic fatty liver disease, which is rapidly becoming a worldwide public health problem. It is more common in the military and Veteran population compared to the general US population. NASH may progress to end-stage liver disease and primary liver cancer, and hence there is critical need for effective treatment. The goal of this clinical trial is to test whether low dose thyroid hormone administered to Veterans diagnosed with NASH can be an effective therapy mediated by improvement in breaking down fat in the mitochondria. The study will be conducted in two stages, the first stage is for proof of concept to be followed by interim analysis. If the interim analysis supports the merit for continuing the study, the clinical trial will proceed to stage 2 for continuation. This study will provide new information and strategies for treatment of NASH using low dose thyroid hormone that will be highly relevant and impactful to the health of the Veteran population.",[533,28],"Nonalcoholic Steatohepatitis",[535,536,537,538],"Thyroid hormone","Nonalcoholic fatty liver disease (NAFLD)","Nonalcoholic steatohepatitis (NASH)","Mitochondrial fatty acid oxidation","2026-02-17",{"date":541,"type":33},"2026-02-19",{"date":543,"type":33},"2023-04-01",{"date":135,"type":21},{"name":546,"class":547},"VA Office of Research and Development","FED",{"id":549,"slug":550,"hasResults":12,"nctId":551,"briefTitle":552,"officialTitle":553,"acronym":4,"eligibilityCriteria":554,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":555,"enrollmentInfo":556,"targetDuration":4,"studyType":22,"phases":558,"briefSummary":559,"conditions":560,"keywords":562,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":564,"lastUpdatePostDateStruct":565,"startDateStruct":566,"completionDateStruct":568,"leadSponsor":570,"locationsCount":77},"100624638","phase-3-a-phase-iiic-clinical-study-to-evaluate-the-long-term-treatment-of-hydronidone-capsules-for-liver-fibrosis-in-patients-with-chronic-hepatitis-b-100624638","NCT07412236","A Phase IIIc Clinical Study to Evaluate the Long-term Treatment of Hydronidone Capsules for Liver Fibrosis in Patients With Chronic Hepatitis B.","A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase IIIc Clinical Study Evaluating the Long-term Treatment of Hepatic Fibrosis in Chronic Hepatitis B With Hydronidone Capsules.","Inclusion Criteria:\n\n* Age 18 to 65 years (inclusive of 18 and 65 years old at the time of signing the informed consent form), male or female;\n* Documented history of chronic hepatitis B and\u002For positive for hepatitis B surface antigen (HBsAg) for ≥6 months;\n* Treatment-naïve or treatment-experienced patients with chronic hepatitis B, defined as follows:\n\n  1. Treatment-naïve patients must meet all of the following criteria:\n\n     * No prior systemic antiviral therapy (e.g., interferon and\u002For nucleos(t)ide analogues) before randomization;\n     * Positive for HBV DNA;\n     * Liver stiffness measurement (LSM) by transient elastography ≥12.4 kPa for treatment-naïve patients with ALT \\>2 × ULN; or LSM ≥10.6 kPa for treatment-naïve patients with ALT ≤2 × ULN. Subjects whose LSM does not meet the above criteria may still be enrolled if they have liver biopsy evidence (within the past 6 months) confirming liver fibrosis of Ishak score ≥3.\n  2. Treatment-experienced patients must meet all of the following criteria:\n\n     * A history of ≥6 months of continuous nucleos(t)ide analogue therapy for hepatitis B up to randomization, currently receiving monotherapy with a nucleos(t)ide analogue \\[e.g., Tenofovir Alafenamide Fumarate (TAF), Tenofovir Disoproxil Fumarate (TDF), or Entecavir (ETV)\\];\n     * HBV DNA positive or negative is acceptable;\n     * Liver stiffness measurement (LSM) by transient elastography \\>9.0 kPa. Subjects whose LSM does not meet the above criteria may still be enrolled if they have liver biopsy evidence (within the past 6 months) confirming liver fibrosis of Ishak score ≥3.\n* ALT \\\u003C8 × ULN;\n* No use within 3 months prior to randomization of the following Chinese patent medicines that may have antifibrotic effects: Fuzhenghuayu Capsule (Tablet), Anluohuaxian Pill, Compound Biejia Ruangan Tablet, etc.;\n* Subjects (or their sexual partners) have no pregnancy plan during the trial and for 6 months after trial completion, voluntarily agree to use effective physical contraceptive methods, and have no plan to donate sperm or eggs;\n* Subjects have fully understood the nature, significance, potential benefits, possible inconveniences, and potential risks of the trial prior to participation, voluntarily agree to take part in this clinical trial, are able to communicate well with the investigators, agree to comply with all study requirements, and have provided written informed consent.\n\nExclusion Criteria:\n\n* Total bilirubin (TBil) \\>3 × ULN, or 3 × ULN \\\u003C ALT \\\u003C8 × ULN with TBil \\>2 × ULN;\n* Platelet count (PLT) ≤50 × 10⁹\u002FL;\n* Prothrombin activity (PTA) \\\u003C50% or International Normalized Ratio (INR) \\>1.5;\n* Imaging findings suggestive of a space-occupying lesion in the liver indicative of tumor, or alpha-fetoprotein (AFP) \\>100 μg\u002FL even in the absence of specific signs of hepatocellular carcinoma;\n* Patients with decompensated liver cirrhosis (complications including ascites, esophageal and\u002For gastric variceal bleeding, spontaneous bacterial peritonitis, hepatorenal syndrome, hepatopulmonary syndrome, hepatic encephalopathy, portal vein thrombosis, and cirrhotic cardiomyopathy) or with hepatic malignancy;\n* Patients with chronic hepatitis C or non-viral chronic hepatitis (alcoholic, drug-induced, etc., excluding metabolic dysfunction-associated steatotic liver disease (MASLD));\n* History of alcohol abuse or inability to abstain from alcohol recently \\[Note: Alcohol abuse is defined as: ① daily ethanol consumption ≥40 g for males or ≥20 g for females for 5 consecutive years; OR ② history of heavy alcohol consumption (\\>80 g of ethanol per day) within the past 2 weeks. Ethanol (g) = volume of alcoholic beverage consumed (mL) × alcohol by volume (%) × 0.8\\];\n* Patients with severe concurrent cardiovascular, pulmonary, renal, endocrine, neurological, or hematological diseases, or psychiatric disorders;\n* Pregnant and\u002For lactating women;\n* Participation in any other drug clinical trial within the past 3 months;\n* Any condition that, in the investigator's judgment, may affect the subject's ability to provide informed consent or comply with the trial protocol, or participation that may affect the trial results or the subject's own safety.","65 Years",{"count":557,"type":21},1208,[24],"This study is conducted as a randomized, double-blind, placebo-controlled, multicenter clinical trial on a background of entecavir therapy. It aims to evaluate the clinical benefits of Hydronidone Capsules in patients with liver fibrosis due to chronic hepatitis B. The study consists of a Screening\u002FBaseline Period (4 weeks) and a Dosing\u002FObservation Period (planned duration of 5 years, including a 52-week primary treatment phase and a 208-week long-term treatment phase).",[28,561],"Liver Fibrosis in Chronic Hepatitis B",[563],"LIver Fibrosis in Chronic Hepatitis B","2026-02-12",{"date":539,"type":33},{"date":567,"type":21},"2026-01-30",{"date":569,"type":21},"2028-12-30",{"name":571,"class":40},"Beijing Continent Pharmaceutical Co, Ltd.",{"id":573,"slug":574,"hasResults":12,"nctId":575,"briefTitle":576,"officialTitle":576,"acronym":577,"eligibilityCriteria":578,"healthyVolunteers":12,"sex":17,"minAge":579,"maxAge":580,"enrollmentInfo":581,"targetDuration":4,"studyType":172,"phases":4,"briefSummary":583,"conditions":584,"keywords":585,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":588,"lastUpdatePostDateStruct":589,"startDateStruct":591,"completionDateStruct":593,"leadSponsor":595,"locationsCount":77},"100616248","non-invasive-assessment-of-liver-fibrosis-in-a-french-cohort-of-pediatric-patients-with-type-iii-glycogen-storage-disease-current-state-and-perspectives-100616248","NCT07303140","Non-invasive Assessment of Liver Fibrosis in a French Cohort of Pediatric Patients With Type III Glycogen Storage Disease: Current State and Perspectives","HEPAGLY","Inclusion Criteria:\n\n* Minors: from birth to 17 years\n* Adults: 18 to 21 years\n* Subjects being monitored for type III glycogen storage disease and having had at least one liver elastography measurement during their follow-up.\n\nExclusion Criteria:\n\n\\- Patients monitored for type III glycogen storage disease but who had never undergone liver elastography during their follow-up.","1 Month","21 Years",{"count":582,"type":21},30,"Patients with type III glycogen storage disease (GSDIII) can develop liver fibrosis, which can be complicated by liver failure or even hepatocellular carcinoma. Since the beginning of the 21st century, non-invasive techniques for assessing fibrosis, such as liver elastography, have been developed. These techniques often make it possible to avoid liver biopsies during patient follow-up and have already been validated in the management of several diseases in adults. These techniques are also beginning to be recommended for monitoring certain chronic liver diseases in children.",[28],[315,586,587],"Type III glycogen storage disease","Liver fibrosis in pediatric patients","2025-12-11",{"date":590,"type":33},"2025-12-24",{"date":592,"type":33},"2024-10-18",{"date":594,"type":21},"2026-02",{"name":596,"class":76},"University Hospital, Strasbourg, France",{"id":598,"slug":599,"hasResults":12,"nctId":600,"briefTitle":601,"officialTitle":602,"acronym":4,"eligibilityCriteria":603,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":604,"targetDuration":4,"studyType":22,"phases":606,"briefSummary":607,"conditions":608,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":609,"lastUpdatePostDateStruct":610,"startDateStruct":612,"completionDateStruct":614,"leadSponsor":616,"locationsCount":77},"100613821","research-on-the-protective-effects-of-phycocyanin-against-liver-fibrosis-and-cirrhosis-100613821","NCT07271576","Research on the Protective Effects of Phycocyanin Against Liver Fibrosis and Cirrhosis","Research on the Role of Phycocyanin in the Prevention, Treatment, and Mechanism of Liver Fibrosis\u002FCirrhosis","Inclusion Criteria:\n\n* Adults between the ages of 18 and 75;\n* Patients diagnosed with liver fibrosis or cirrhosis;\n* Voluntary participation in this study and signing of an informed consent form;\n* No acute diseases or significantly worsening symptoms for at least 4 weeks prior to enrollment.\n\nExclusion Criteria:\n\n* Presence of severe comorbidities;\n* Allergy to phycocyanin;\n* Patients with a history of severe mental illness that may affect treatment compliance.",{"count":605,"type":21},10,[54],"This clinical trial aims to determine whether phycocyanin, a natural protein derived from spirulina, can help treat liver fibrosis or cirrhosis in adult patients. The main questions it aims to answer are:\n\n* Can phycocyanin reduce blood levels of liver enzymes (such as ALT and AST) that indicate liver damage?\n* Can phycocyanin improve liver stiffness as measured by ultrasound?\n\nResearchers will compare the phycocyanin intervention group with a control group that receives a placebo (a similar-looking maltodextrin supplement without active ingredients) to explore if phycocyanin is more effective in treating liver fibrosis\u002Fcirrhosis.\n\nParticipants will:\n\n* Take one sachet of either phycocyanin or placebo daily for at least 4 weeks.\n* Attend regular clinic appointments (typically every 2-3 months) for routine monitoring of your liver condition, which will include blood and urine tests.\n* Provide blood and stool samples once before the treatment and once after the 4-week treatment period.\n* Undergo an ultrasound evaluation of liver stiffness.\n\nThe study will last approximately 2 years, and the personal information of all patients will be kept strictly confidential.",[28,175],"2025-12-07",{"date":611,"type":33},"2025-12-09",{"date":613,"type":33},"2025-06-04",{"date":615,"type":21},"2027-06-04",{"name":617,"class":76},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":619,"slug":620,"hasResults":12,"nctId":621,"briefTitle":622,"officialTitle":623,"acronym":4,"eligibilityCriteria":624,"healthyVolunteers":119,"sex":17,"minAge":18,"maxAge":625,"enrollmentInfo":626,"targetDuration":4,"studyType":22,"phases":628,"briefSummary":630,"conditions":631,"keywords":632,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":634,"lastUpdatePostDateStruct":635,"startDateStruct":637,"completionDateStruct":639,"leadSponsor":641,"locationsCount":77},"100613112","phase-1-the-phase-d-clinical-trial-of-hydronidone-capsules-100613112","NCT07262346","The Phase Ⅰd Clinical Trial of Hydronidone Capsules","Clinical Pharmacokinetic Study of Hydronione Capsules in Healthy Chinese Subjects (Ⅰd)","Inclusion Criteria:\n\n1. Healthy subjects, both male and female;\n2. Age: 18-45 years;\n3. Weight: Male ≥50 kg, Female ≥45 kg, with a BMI between 19 and 26 (BMI = weight (kg)\u002Fheight² (m²));\n4. Pass a comprehensive health examination, meaning no abnormalities or no clinically significant findings in the following: vital signs, physical examination, blood and urine routine tests, blood pregnancy test, blood glucose, blood lipids, blood electrolytes, hepatitis B surface antigen, liver and kidney function, hepatitis C, HIV and syphilis antibody tests, 12-lead electrocardiogram, nicotine screening, urine drug screening, alcohol breath test, chest X-ray, etc.;\n5. Have been fully informed about the nature, significance, potential benefits, possible inconveniences, and risks of the study prior to participation, and voluntarily agree to take part in this clinical trial. Subjects must be able to communicate well with the researchers, comply with all study requirements, and have the capacity to understand and sign the written informed consent form.\n\nExclusion Criteria:\n\n1. (Inquiry) Participation in any other clinical trial within three months prior to this study;\n2. (Inquiry) Presence of any disease that may affect the safety of the trial or the pharmacokinetics of the drug, including but not limited to: past or current diseases of the heart, liver, kidneys, endocrine system, digestive tract, immune system, respiratory system, nervous system, or psychiatric disorders \\[particularly cardiovascular diseases or individuals at risk of cardiovascular diseases, any gastrointestinal diseases affecting drug absorption (e.g., irritable bowel syndrome, inflammatory bowel disease), active pathological bleeding (e.g., peptic ulcer), urticaria, epilepsy, allergic rhinitis, eczematous dermatitis, asthma, active tuberculosis, etc.\\];\n3. (Inquiry) Allergic constitution: such as a history of drug or food allergies, skin allergies, or lactose intolerance;\n4. (Inquiry) Use of any drugs that inhibit or induce hepatic drug metabolism within 28 days before taking the investigational drug (common enzyme inducers: barbiturates such as phenobarbital, carbamazepine, aminoglutethimide, griseofulvin, meprobamate, phenytoin, glutethimide, rifampicin, dexamethasone; common enzyme inhibitors: chlorpromazine, cimetidine, ciprofloxacin, metronidazole, chloramphenicol, isoniazid, sulfonamides);\n5. Use of any medications (including herbal medicines) or health products within 14 days before the first dose;\n6. (Inquiry) Individuals with special dietary requirements who cannot adhere to a standardized diet (e.g., intolerance to standard meals) or those with difficulty swallowing;\n7. (Inquiry) Inability to tolerate venipuncture and\u002For a history of blood or needle phobia;\n8. (Inquiry) Habitual excessive consumption of tea, coffee, or caffeine-containing beverages (more than 8 cups per day, 1 cup = 250 mL); or consumption of any caffeine-containing foods or beverages (e.g., coffee, strong tea, chocolate, etc.) within 48 hours before the first dose, or adherence to any special diet that may affect drug absorption, distribution, metabolism, or excretion;\n9. (Inquiry) History of excessive alcohol consumption (defined as more than 28 standard units per week for men and more than 21 standard units per week for women (1 standard unit contains 14 g of alcohol, equivalent to 360 mL of beer, 45 mL of 40% spirits, or 150 mL of wine)); or regular alcohol consumption (more than 14 standard units per week) within 6 months prior to the trial; or consumption of any alcohol-containing products within 24 hours before the first dose;\n10. (Inquiry) Blood donation or significant blood loss (exceeding 450 mL) within 3 months before the first dose, or plans to donate blood or blood components during the study or within 3 months after its completion;\n11. (Inquiry) Occurrence of an acute illness during the pre-study screening phase or before administration of the study drug;\n12. (Inquiry) Consumption of any foods or beverages known to induce or inhibit hepatic metabolic enzymes (e.g., grapefruit, mango, dragon fruit, grape juice, orange juice, etc., which are rich in flavonoids or citrus glycosides) within 24 hours before the first dose;\n13. (Inquiry) Surgery within three months before screening or plans to undergo surgery during the study period;\n14. (Inquiry) History of drug abuse or substance abuse;\n15. (Inquiry) Smoking more than 5 cigarettes per day within 14 days before screening, or inability to discontinue the use of any tobacco products during the trial period;\n16. (Inquiry) Smoking or use of any tobacco products between screening and hospital admission;\n17. Positive nicotine test result;\n18. Alcohol breath test result greater than 0.0 mg\u002F100 mL;\n19. Positive urine drug screen result;\n20. Pregnant or breastfeeding women;\n21. Individuals planning to conceive within 6 months after the trial or unwilling to use non-pharmacological contraceptive measures;\n22. Any condition deemed by the investigator as potentially affecting the subject's ability to provide informed consent, comply with the trial protocol, or participate in the trial in a way that could impact the results or subject safety.","45 Years",{"count":627,"type":21},138,[629],"PHASE1","Based on the Phase I (Ia, Ib, Ic) clinical pharmacokinetic study of Hydronidone Capsules, a clinical pharmacokinetic trial of Hydronidone Capsules (specification: 30 mg\u002Fcapsule) was conducted, including single-dose administration, multiple-dose administration, and a food-effect study. The aim was to investigate the safety, tolerability, and pharmacokinetic characteristics of higher doses of Hydronidone Capsules (specification: 30 mg\u002Fcapsule) in healthy subjects, in preparation for future expansion of indications.",[28],[633],"Hydronidone","2025-11-21",{"date":636,"type":33},"2025-12-03",{"date":638,"type":21},"2025-12-05",{"date":640,"type":21},"2026-05-05",{"name":571,"class":40},{"id":643,"slug":644,"hasResults":12,"nctId":645,"briefTitle":646,"officialTitle":647,"acronym":4,"eligibilityCriteria":648,"healthyVolunteers":119,"sex":17,"minAge":18,"maxAge":555,"enrollmentInfo":649,"targetDuration":4,"studyType":172,"phases":4,"briefSummary":651,"conditions":652,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":654,"lastUpdatePostDateStruct":655,"startDateStruct":657,"completionDateStruct":659,"leadSponsor":660,"locationsCount":4},"100605901","is-there-a-relationship-between-uric-acid-level-and-liver-fibrosis-in-obese-patients-100605901","NCT07168551","Is There a Relationship Between Uric Acid Level and Liver Fibrosis in Obese Patients","Association of Hyperuricemia and Non Alcoholic Fatty Liver Disease and Liver Fibrosis Risk in Adult Obese Patients","Inclusion Criteria:\n\n1. Age: Adults (typically 18-65 years old)\n\n2 - Body Mass Index (BMI): Obese patients with a BMI ≥ 30 kg\u002Fm²\n\n3- Hyperuricemia : Elevated serum uric acid levels (typically \\> 7 mg\u002FdL for men and \\> 6 mg\u002FdL for women)\n\nExclusion Criteria:\n\n* excessive alcohol consumption ( \\> 20 gm \u002Fday in men and 10 in g \u002Fday in women )\n\n  2- use of steatogenic within the past 6 months\n\n  3- positive test for hepatitis B surface antigen and hepatitis B core antibody\n\n  4- Drug induced liver injury and autoimmune hepatitis\n\n  5 - cirrhosis and other causes of liver disease",{"count":650,"type":21},111,"1. Identifying the association between hyperuricemia and NAFLD can lead to early detection and prevention of liver fibrosis in adult obese patients.\n2. Understanding the relationship between hyperuricemia and NAFLD can inform targeted therapy, such as urate-lowering treatment, to potentially slow disease progression.\n\n3 - To examine the relationship between serum uric acid levels and liver fibrosis severity\\*: Assessing the correlation between serum uric acid levels and the severity of liver fibrosis in adult obese patients with NAFLD.\n\n4- To identify potential mechanisms underlying the association\\*: Exploring the potential mechanisms by which hyperuricemia may contribute to the development and progression of NAFLD and liver fibrosis in adult obese patients.",[653,176,28],"Hyperuricemia","2025-09-12",{"date":656,"type":33},"2025-09-15",{"date":658,"type":21},"2025-10-01",{"date":518,"type":21},{"name":425,"class":76},{"id":662,"slug":663,"hasResults":12,"nctId":664,"briefTitle":665,"officialTitle":666,"acronym":4,"eligibilityCriteria":667,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":668,"targetDuration":4,"studyType":22,"phases":670,"briefSummary":671,"conditions":672,"keywords":675,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":680,"lastUpdatePostDateStruct":681,"startDateStruct":683,"completionDateStruct":685,"leadSponsor":686,"locationsCount":688},"100476971","phase-1-single-and-multiple-dose-escalation-of-phin-214-in-child-pugh-a-and-b-liver-cirrhotics-100476971","NCT05490888","Single and Multiple Dose Escalation of PHIN-214 in Child-Pugh A and B Liver Cirrhotics","A Phase 1 Open Label Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PHIN-214 in Adults With Child Pugh A and B Cirrhosis","Key Inclusion Criteria:\n\n1. History of cirrhosis based on histology or a combination of clinical, radiological, or biochemical assessment and classified as Child-Pugh A or B\n2. Participants may be male or female aged 18 to 75 years.\n3. Body mass index (BMI) within the range 18 to 40 kg\u002Fm2 (inclusive) at screening.\n4. Female participants must be non-pregnant, non-lactating, or of non-childbearing potential or using highly efficient contraception for the full duration of the study\n\nKey Exclusion Criteria:\n\n1. Significant abnormalities in medical history or on physical examination, including: respiratory disease requiring therapy or history of respiratory failure, cardiovascular disease or hypertension, electrocardiogram abnormalities or history of significant EKG abnormalities.\n2. History of diabetes insipidus, syndrome of inappropriate antidiuretic hormone secretion, or any other disorder associated with fluid or sodium imbalance.\n3. Significant kidney disease\n4. Hepatic encephalopathy (HE) or altered mental status requiring hospitalization; variceal bleeding or upper gastrointestinal bleeding; or type 1 hepatorenal syndrome with acute kidney injury (HRS-AKI) during the previous 3 months prior to Screening.\n5. Acute-on-chronic liver failure.\n6. Recipient of a patent transjugular intrahepatic portosystemic shunt (TIPS).\n7. Known positive HIV serology confirmed by HIV viral load.\n8. Subjects with acute infections, including acute viral hepatitis (subjects with chronic hepatitis B are eligible if treatment regimen is stable ≥ 3 months prior to study inclusion).",{"count":669,"type":21},74,[629],"This 2-part study will evaluate PHIN-214 given as a single one-time dose (Part 1) and in multiple doses (given as daily doses for 28-days) (in Part 2). Specifically, this study evaluates PHIN-214, to determine the safety, tolerability, and pharmacokinetic effects of PHIN-214, and to establish the maximum tolerated dose or optimal beneficial dose in patients with Child Pugh A and B Cirrhosis.",[673,28,674],"Cirrhosis, Liver","Ascites Hepatic",[676,677,678,679],"Terlipressin","Cirrhosis","Vasoconstrictor","Refractory Ascites","2025-09-03",{"date":682,"type":33},"2025-09-05",{"date":684,"type":33},"2022-01-03",{"date":204,"type":21},{"name":687,"class":40},"PharmaIN",9]