[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hepatic-encephalopathy-he\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hepatic-encephalopathy-he":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,45,73,100,122],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100625992","phase-1-egen-5784-porcine-liver-with-the-metra-elc-device-100625992",false,"NCT07429838","EGEN-5784 Porcine Liver With the Metra® ELC Device","A Phase 1, First-in-Human Safety and Proof-of-Concept Study to Evaluate EGEN-5784 Porcine Liver (Drug Product) in Combination With the Metra® Extra-Corporeal Liver Cross-Circulation Device in Participants With Acute-on-Chronic Liver Failure","Key Inclusion Criteria:\n\n* Male or female, age 18 to 70 years, inclusive\n* Not eligible for transplantation at the time of enrollment\n* Diagnosis of Grade 2 to 3 ACLF according to the European Association for the Study of Chronic Liver Failure (EASL-CLIF) definition and Chronic Liver Failure Consortium-organ failure score (CLIF-C-OF) ≥10\n* Hepatic encephalopathy Grade 1 to 3 by West Haven Criteria\n* Written consent provided by participant or LAR (if participant lacks capacity, e.g., due to hepatic encephalopathy) prior to conduct of any study procedures\n\nKey Exclusion Criteria:\n\n* Prior solid organ transplant\n* Fulminant hepatic failure without underlying liver disease\n* Non-biological artificial liver extracorporeal liver support (e.g., molecular adsorbent recirculating system) or bioartificial liver support systems within 30 days prior to EGEN-5784 liver perfusion\n* Liver dysfunction due to trauma, or extra-hepatic cholestasis\n* Any uncontrolled ongoing active infection\n* History or active human immunodeficiency virus (HIV) infection or acute hepatitis B virus (HBV)\n* Chronic HBV or active hepatitis C\n* Diagnosis of cancer requiring active ongoing treatment, e.g., chemotherapy, radiation therapy\n* Severe concomitant cardiovascular disease defined as congestive heart failure Class III and IV\n* Significant acute or chronic pulmonary disease requiring ventilator support or diagnosed with chronic obstructive pulmonary disease Global Obstructive Lung Disease \\[GOLD\\] stage III or IV disorder\n* Active uncontrolled bleeding (i.e., any major blood loss requiring ≥2 units of pRBCs within the last 48 hours prior to screening)\n* Any other health condition, including illicit drug use, that would preclude participation in the study in the judgement of the PI","ALL","18 Years","70 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This is a Phase 1, first-in-human (FIH) safety, proof-of-concept, two-part study of the genetically-engineered EGEN-5784 liver in combination with the metra® extra-corporeal liver cross-circulation (ELC) system in participants with Grade 2 to Grade 3 acute-on-chronic liver failure (ACLF) and hepatic encephalopathy Grade 1-3. The metra® device has been modified for the purposes of cross-circulation with an extra-corporeal porcine liver. The EGEN-5784 liver and metra® ELC device are designed to support liver function during the treatment period",[27,28],"Acute on Chronic Liver Failure (ACLF)","Hepatic Encephalopathy (HE)",[30,31],"Extra-corporeal live cross-circulation","Metra","NOT_YET_RECRUITING","2026-05-05",{"date":35,"type":36},"2026-05-07","ACTUAL",{"date":38,"type":21},"2026-06",{"date":40,"type":21},"2028-01",{"name":42,"class":43},"eGenesis, INC","INDUSTRY",2,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":44},"100619825","underdilated-stent-technique-improves-post-tips-encephalopathy-100619825","NCT07349654","Underdilated-stent Technique Improves Post-TIPS Encephalopathy","Underdilated-stent Technique Improves Post-transjugular Intrahepatic Portosystemic Shunt Encephalopathy: a Randomized Controlled Trial","Inclusion Criteria:\n\n* Liver cirrhosis, defined by clinical manifestations, biochemical indicators, imaging examinations, or liver biopsy;\n* History of esophagogastric variceal bleeding, or refractory\u002Frecurrent ascites;\n* Intended to undergo TIPS treatment.\n\nExclusion Criteria:\n\n* Non-cirrhotic portal hypertension;\n* Previous treatments that may affect portal pressure, such as TIPS or surgical procedures;\n* History of overt hepatic encephalopathy (West-Haven classification ≥2);\n* Malignant tumors in advanced stages;\n* Concomitant irreversible heart, liver, kidney, or respiratory failure;\n* Unable or unwilling to sign the informed consent form.","75 Years",{"count":54,"type":21},72,[56],"NA","Transjugular intrahepatic portosystemic shunt (TIPS) is a critical therapeutic approach for managing esophagogastric variceal bleeding and refractory ascites in decompensated cirrhosis patients. To date, hepatic encephalopathy (HE) remains one of the most common complications following TIPS procedures, and prediction and prevention of post-TIPS HE have always been a hotspot in the field of hepatology. However, no reliable clinical studies have confirmed that any drug or intervention can effectively prevent the occurrence of HE episodes following TIPS, including lactulose and rifaximin.\n\nUnderdilated strategy (UDS) was reported as an development technique proposed in recent years for TIPS procedures, which involves using a small-diameter balloon to dilate the puncture tract and subsequently implanted standard-diameter covered stent (e.g., 8 mm). This allows the stent to maintain a smaller diameter shortly after release, thereby reducing the incidence of hepatic encephalopathy during the postoperative period. Over time, the stent gradually dilates to its normal diameter within months. This period coincides with the higher incidence risk of post-TIPS HE, most commonly occurring within 6 months, especially within the first 3 months after TIPS. Therefore, theoretically, UDS can reduce the occurrence of post-TIPS HE. In terms of clinical research, however, there were still no high quality studies reported the advantages of this technique. Current reported clinical studies were all non-randomized controlled trials or retrospective studies, with low-quality evidence and sometimes contradictory findings.\n\nThe aim of this prospective randomized controlled clinical study is to evaluate whether administration of underdilated technology during TIPS can improve postoperative hepatic encephalopathy, without compromising the therapeutic efficacy of portal hypertension complications.",[59,60,61,28],"Liver Cirrhosis","Variceal Bleeding, Cirrhosis","Ascites Hepatic","RECRUITING","2026-01-09",{"date":65,"type":36},"2026-01-20",{"date":67,"type":36},"2024-11-19",{"date":69,"type":21},"2027-12-31",{"name":71,"class":72},"The Second Affiliated Hospital of Chongqing Medical University","OTHER",{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":22,"phases":84,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":97,"locationsCount":99},"100613987","udca-to-prevent-post-tips-hepatic-encephalopathy-100613987","NCT07273734","UDCA to Prevent Post-TIPS Hepatic Encephalopathy","A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Ursodeoxycholic Acid Plus Lactulose vs Lactulose Alone for the Prevention of Overt Hepatic Encephalopathy After TIPS Placement","THEUDCA","Inclusion Criteria:\n\n* Age 18-80 years.\n* Confirmed cirrhosis (biopsy, elastography, or standard radiologic\u002Fbiochemical criteria).\n* Elective TIPS for (a) refractory\u002Frecurrent ascites and\u002For (b) recurrent variceal bleeding not responsive to treatment with endoscopic band ligation and beta-blockers.\n* Preemptive TIPS for patients with variceal bleeding and Child-Pugh C (10-13 points), patients with Child-Pugh B and active bleeding during endoscopy, or patients with hepatic venous pressure gradient (HVPG) ≥ 20 mmHg.\n* Ability to start study drug within 72 hours before TIPS.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Contraindications to TIPS (e.g., severe heart failure ≥NYHA III, severe pulmonary hypertension, uncontrolled sepsis, advanced HCC at risk with TIPS, unrelieved biliary obstruction, Child-Pugh score \\>13, main-trunk PVT if not recanalizable, technical infeasibility).\n* Prior OHE grade II-IV without precipitating factor; overt neurological disease affecting cognition (e.g., Parkinson's, Alzheimer's).\n* Current or planned ursodeoxycholic acid (UDCA) therapy for an approved indication (e.g., primary biliary cholangitis), or UDCA use within the prior 3 months.\n* Current\u002Frecent rifaximin use (\\\u003C3 months) or strong UDCA contraindication\u002Fhypersensitivity.\n* Salvage TIPS.\n* Non-cirrhotic portal hypertension.\n* Pregnancy\u002Flactation.\n* Any condition that, in investigators' judgment, precludes safe participation.","80 Years",{"count":83,"type":21},270,[56],"Hepatic encephalopathy (HE) commonly occurs after transjugular intrahepatic portosystemic shunt (TIPS). Ursodeoxycholic acid (UDCA) has been reported to alleviate neurodegenerative disease recently. This open-label multicenter randomized controlled trial tests whether adding UDCA (13-15 mg\u002Fkg\u002Fday) to standard lactulose prophylaxis reduces the incidence of overt HE (OHE; West Haven grade II-IV) after TIPS, compared with lactulose alone. The regimen starts within 72 hours before TIPS and continues for 3 months. The trial aims to evaluate the effect of UDCA in reducing the incidence of post-TIPS OHE.",[28,87],"TIPS",[87,89,28,90],"UDCA","Ursodeoxycholic acid","2025-11-26",{"date":93,"type":36},"2025-12-09",{"date":95,"type":21},"2026-01-01",{"date":69,"type":21},{"name":98,"class":72},"West China Hospital",1,{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":106,"enrollmentInfo":107,"targetDuration":4,"studyType":109,"phases":4,"briefSummary":110,"conditions":111,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":99},"100604490","study-on-proteomic-and-microbiome-changes-in-patients-with-hepatic-encephalopathy-he-100604490","NCT07150195","Study on Proteomic and Microbiome Changes in Patients With Hepatic Encephalopathy (HE)","Inclusion Criteria:\n\nFor the NHE (No Hepatic Encephalopathy) Group:\n\n1. Aged between 18 and 85 years, inclusive.\n2. Diagnosis of liver cirrhosis.\n3. Normal blood ammonia level.\n4. West-Haven Criteria grade 0 for Hepatic Encephalopathy.\n5. Normal neurological signs.\n6. Normal neuropsychological test results.\n7. Willing to participate and provides written informed consent.\n\nFor the CHE (Covert Hepatic Encephalopathy) Group:\n\n1. Aged between 18 and 85 years, inclusive.\n2. Diagnosis of liver cirrhosis.\n3. Elevated blood ammonia level.\n4. Diagnosis of Covert Hepatic Encephalopathy (West-Haven Criteria grade 0 or I).\n\n   * Grade 0: No personality or behavioral changes but abnormal neuropsychological tests.\n   * Grade I: Mild cognitive impairment, lack of awareness, euphoria or anxiety, shortened attention span, or impaired performance of addition\u002Fsubtraction.\n5. Neurological signs are normal or mild asterixis (flapping tremor) may be elicited.\n6. Neuropsychological tests are abnormal.\n7. Willing to participate and provides written informed consent.\n\nExclusion Criteria:\n\n1. Diagnosis of any malignant tumor.\n2. History of treatment for any malignant tumor.\n3. Presence of severe concomitant cardiac, pulmonary, cerebral, or renal diseases, or severe diabetic complications.\n4. Use of antibiotics, prebiotics, probiotics, or proton pump inhibitors within the three months prior to enrollment.\n5. Pregnancy, lactation, or puerperium.","85 Years",{"count":108,"type":21},32,"OBSERVATIONAL","The objective of this observational study is to compare the differences in proteomics and gut microbiome between the liver cirrhosis group without hepatic encephalopathy and the hepatic encephalopathy group through proteomics and microbiome analysis, screen out the characteristic proteomics and microbiome of patients with hepatic encephalopathy, guide clinical diagnosis and treatment, and conduct in-depth research on the pathogenesis of hepatic encephalopathy. The main questions it aims to answer are:\n\nAre there any differences in serum proteomes between patients with liver cirrhosis without hepatic encephalopathy and those with hepatic encephalopathy? If so, what are the main protein differences? There are differences in the fecal microbiome between patients with liver cirrhosis without hepatic encephalopathy and those with hepatic encephalopathy? If so, what are the main microbial differences?\n\nThis study will screen for the differences in proteomes and gut microbiomes between patients with liver cirrhosis without hepatic encephalopathy and those with hepatic encephalopathy, and identify the characteristic proteomes and microbiomes of patients with hepatic encephalopathy to guide clinical diagnosis and treatment.",[112,28],"Cirrhoses, Liver","2025-09-23",{"date":115,"type":36},"2025-09-25",{"date":117,"type":21},"2025-09",{"date":119,"type":21},"2026-12",{"name":121,"class":72},"The First Affiliated Hospital with Nanjing Medical University",{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":126,"acronym":4,"eligibilityCriteria":127,"healthyVolunteers":128,"sex":16,"minAge":17,"maxAge":129,"enrollmentInfo":130,"targetDuration":4,"studyType":109,"phases":4,"briefSummary":132,"conditions":133,"keywords":136,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":99},"100587043","70t-magnetic-resonance-imaging-study-for-hepatic-encephalopathy-100587043","NCT06923254","7.0T Magnetic Resonance Imaging Study for Hepatic Encephalopathy","Inclusion Criteria:\n\n* Patients with clinical suspected or diagnosed hepatic encephalopathy according to relevant guidelines.The patient's education level is above primary school level.\n* Regular follow-up.\n\nExclusion Criteria:\n\n* Contraindications to MRI.\n* Patients with cerebrovascular disease, brain tumors, epilepsy, other neurodegenerative disease.",true,"89 Years",{"count":131,"type":21},200,"This clinical trial study aims to detect the imaging characteristics of patients with hepatic encephalopathy (HE) using 7-Tesla (7T) magnetic resonance imaging (MRI).",[28,134,135],"MRI","fMRI Research",[137,138],"Hepatic Encephalopathy","fMRI","2025-04-04",{"date":141,"type":36},"2025-04-11",{"date":143,"type":21},"2025-04-03",{"date":145,"type":21},"2030-12-24",{"name":147,"class":72},"Chinese PLA General Hospital"]