[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"immune-mediated-hepatitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:immune-mediated-hepatitis":56},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,43,72,98,127],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100644358","phase-2-mycophenolate-mofetil-w-prednisone-for-immune-related-hepatitis-from-checkpoint-inhibitor-therapy-100644358",false,"NCT07663422","Mycophenolate Mofetil w\u002F Prednisone for Immune Related Hepatitis From Checkpoint Inhibitor Therapy","GU-228: Mycophenolate Mofetil in Combination With Prednisone as First-line Treatment of Immune Related Hepatitis Resulting From Checkpoint Inhibitor Therapy","Inclusion Criteria:\n\n* Patients must be ≥ 18 years at the time of irAE diagnosis and must have been diagnosed with a solid tumor or hematologic malignancy being treated with non-curative intent.\n* Patients must be diagnosed or presumed to have by a treating Medical Oncology or Hematology-Oncology clinician with immune-related hepatitis, G2-G3 (as defined in section 11.0), with plan for at least temporary interruption of IO therapy and initiation of corticosteroid treatment.\n* Patients must have been previously treated for any malignancy with at least one dose of an IO agent targeting the Programmed cell death protein 1 (PD-1)\u002Fprogrammed death-ligand 1 (PDL-1) or CTLA-4 axis. IO use may have occurred at any time prior to diagnosis of irAE.\n* Serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), and total bilirubin must have been measured within screening window outlined in Section 8.0 (Study Calendar).\n* Patient must be able to take study medications by mouth.\n* Baseline hemoglobin (HgB) at time of enrollment ≥8.0 g\u002FdL, absolute neutrophil count (ANC) ≥ 1500\u002Fmm3, and platelet count ≥ 100,000\u002Fmm3 without red blood cell or platelet transfusion in the two weeks preceding measurement of lab values. Lab values are to be assessed within screening window outlined in Section 8.0 (Study Calendar).\n* Baseline estimated Glomerular Filtration Rate (eGFR) \\\u003C 30 mL\u002Fmin\u002F1.73m2\n* Patients must be able to understand and willing to sign a written informed consent and HIPAA consent document.\n\nExclusion Criteria:\n\n* Patients previously treated for irAE hepatitis.\n* Patients diagnosed or presumed to have G4 immune-related hepatitis.\n* Patients receiving renal replacement therapy with hemodialysis or peritoneal dialysis at time of enrollment.\n* Patients with a documented history of Child-Turcotte-Pugh class B and C liver dysfunction.\n* Patients with significant liver dysfunction at time of presentation, as defined by an otherwise unexplained change in mental status or International Normalized Ratio (INR) ≥ 1.5 attributed to synthetic liver dysfunction.\n* Patients with active hepatitis B (HBV), hepatitis C (HCV), or tuberculosis. Confirmatory testing for these infections may be performed if no recent result is available in the patient's records and, in the opinion of the treating physician, such testing is clinically warranted. Past HBV is exclusionary. Patients with treated HCV infection and documented eradication are eligible to enroll.\n* Patients with uncontrolled human immunodeficiency virus (HIV), Epstein-Barr virus (EBV), cytomegalovirus (CMV), herpes simplex virus (HSV), or Varicella-zoster virus (VZV). Confirmatory testing for these infections is not required.\n* Patients with a history of gastrointestinal bleeding, ulceration, or perforations within one year of trial enrollment. Use of proton-pump inhibitor therapy is allowed.\n* Patients with any history of solid organ or allogeneic stem cell transplantation.\n* Patients with type I diabetes mellitus (DM).\n* Patients with type II DM with most recent glycated hemoglobin measurement greater than or equal to 9.0%.\n* Patients with a documented history of phosphoribosyl-transferase deficiency.\n* History of allergic reactions to MMF, prednisone, methylprednisolone, or dexamethasone.\n* Patients with decompensated congestive heart failure at time of enrollment, at the discretion of treating clinician, regardless of ejection fraction.\n* Patients with history of suicidal ideation or past suicide attempt.\n* Uncontrolled or intercurrent severe medical illness at the time of enrollment, as defined below:\n\n  1. Patients being treated with vasopressors\n  2. Patient requiring mechanical ventilation or extracorporeal membrane oxygenation\n  3. Patients being treated with parenteral antibiotic, antifungal, or antiviral medications\n* Patients with chronic autoimmune diseases requiring long-term immunosuppressive treatment at the time of enrollment, or for whom the mechanism of index inflammatory changes is too uncertain to initiate irAE-directed treatment at the discretion of treating provider.\n* Patients with congenital (e.g. combine variable immunodeficiency) or acquired (e.g. chronic leukemia) immunodeficiency requiring long-term prophylactic antimicrobial treatment at time of enrollment (e.g. intravenous immunoglobulin (IVIg), prophylactic antiviral treatment, etc.)\n* Women of child-bearing potential (WOCBP) who are pregnant or breast-feeding.\n* Patients unable to commit to use of reliable contraception throughout the study period.","ALL","18 Years",{"count":19,"type":20},31,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This phase II study evaluates whether early treatment with mycophenolate mofetil (MMF) plus prednisone improves liver inflammation caused by immune checkpoint inhibitors. The study includes patients who develop moderate to severe immune-related hepatitis after receiving PD-(L)1 or CTLA-4-based cancer therapy. The main goal is to determine how many patients experience improvement in liver function within 30 days while successfully tapering steroids. Safety and treatment-related side effects will also be monitored.",[26,27],"Immune-mediated Hepatitis","Immune-related Adverse Event",[29,30,27],"irAE","Immune-mediated hepatitis","NOT_YET_RECRUITING","2026-06-17",{"date":34,"type":35},"2026-06-23","ACTUAL",{"date":37,"type":20},"2026-06-30",{"date":39,"type":20},"2028-09-30",{"name":41,"class":42},"Fox Chase Cancer Center","OTHER",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":69,"locationsCount":71},"100399083","checkpoint-inhibitor-induced-liver-injury-100399083","NCT04476563","Checkpoint Inhibitor-induced Liver Injury","Checkpoint Inhibitor-induced Liver Injury Study (ChILI)","ChILI","Inclusion Criteria:\n\nBoth patient groups and control group:\n\n• Able to give written informed consent OR Potential participants who have developed encephalopathy related to ChILI as a response to checkpoint inhibitor therapy, who lack the capacity to give written informed consent and have a consultee (personal or nominated) - for ChILI patient group only\n\nChILI group:\n\nPatients who developed checkpoint inhibitor-induced liver injury and meet the following criteria:\n\n1. Meets one of the following analytical thresholds at enrolment (visit 1)\n\n   * Alanine transaminase (ALT) exceeding 5 times the upper limit of normal (ULN) OR\n   * ALT exceeding 3 times ULN plus bilirubin exceeding 2 times ULN OR\n   * Alkaline phosphatase (ALP) exceeding 2 times ULN with accompanying elevations of gamma-glutamyl transferase in the absence of known bone metastases driving the rise in ALP level\n2. Absence of other known causes of liver injury after detailed investigations\n\nPatients who developed ChILI but did not meet the above criteria at enrolment or who were found to have a different cause for their liver injury after further investigations will be excluded from the analysis\n\nControl group:\n\nConsecutive patients with cancer who have a clinical indication to start checkpoint inhibitors. A small proportion of patients will develop ChILI following their checkpoint inhibitor treatment and will be classified as cases.\n\nExclusion Criteria:\n\n* Patients who are treated with cytotoxic chemotherapy concurrently with checkpoint inhibitors.\n* On the judgment of chief investigator that the person has certain alternative explanations to the acute event (rather than ChILI).",{"count":52,"type":20},160,"OBSERVATIONAL","In this multi-center prospective observational study, the investigators plan to identify the incidence and risk factors for checkpoint inhibitor-induced liver injury and characterize biochemical, genetic, immunological, and histological features associated with it.",[56],"Immune-Mediated Hepatitis",[58,59,60,61],"Immune checkpoints inhibitors","Immune-related adverse events","Hepatotoxicity","Liver injury","RECRUITING","2026-03-23",{"date":65,"type":35},"2026-03-24",{"date":67,"type":35},"2020-10-13",{"date":37,"type":20},{"name":70,"class":42},"University of Nottingham",1,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":82,"conditions":83,"keywords":84,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":71},"100552277","specific-biomarkers-of-immune-mediated-hepatitis-secondary-to-immune-checkpoint-inhibitors-100552277","NCT06470997","Specific Biomarkers of Immune-mediated Hepatitis Secondary to Immune Checkpoint Inhibitors","Specific Biomarkers of Immune-mediated Hepatitis Secondary to Immune Checkpoint","Pro-CHILI","Inclusion criteria for patients in the CHILI group:\n\n* Patient \\> 18 years old\n* Patient treated with immune checkpoint inhibitors (ICI) alone or in combination\n* Patient suffering from Hepatitis secondary to immune checkpoint inhibitors (ICI) grade 3 or 4 Common Terminology Criteria For Adverse Events (CTCAE)\\*\n* Treatment with corticosteroids or Ursodeoxycholic acid (UDCA) not started, or started less than 30 days ago\n\n  * Grade 3 or 4 hepatitis: increase in transaminases and\u002For alkaline phosphatases ≥ 5 x Upper Limit of Normal (ULN) or total bilirubin ≥ 3\n\nInclusion criteria for patients in the control group:\n\n* Patient \\> 18 years old\n* Patient suffering from Primary Biliary Cholangitis (PBC)\\* or Autoimmune Hepatitis (AIH)\\*\\* or Primary Sclerosing Cholangitis (PSC) \\*\\*\\*\n\nPrimary Biliary Cholangitis (PBC)\\* diagnosis :\n\nAssociation of at least 2 of the following 3 criteria :\n\n* Cholestasis (PAL \\> 1.5N, Gamma GT \\> 3N) chronic (\\> 6 months) without ultrasound abnormality of the bile ducts.\n* M2 type anti-mitochondria Ab \\> 1\u002F40th\n* Characteristic histological lesions (non-suppurative destructive cholangitis) or compatible (portal inflammation, granulomas, ductular proliferation, ductopenia, cholestasis).\n\n  \\*\\* AIH diagnosis : ALT \\> 5 N \u002F Ig G \\> 1.5 - 2 N or anti-smooth muscle ≥ 1\u002F80 \u002F Interface hepatitis of marked intensity The Hepactic Activity Index (HAI) score makes it possible to confirm the diagnosis when all the diagnostic criteria are not met.\n\n  \\*\\*\\* PSC diagnosis: presence of chronic cholestasis (alkaline phosphatase \\> 1.5 N or GGT \\> 3 N) and typical abnormalities of the bile ducts on cholangio-MRI (Magnetic Resonance Imaging), and in the absence of cause of secondary sclerosing cholangitis\n* Treatment with corticosteroids or Ursodeoxycholic acid (UDCA) not initiated, or started less than 30 days ago\n\nNon-inclusion criteria:\n\n* Impossibility of following the patient during the study period\n* Liver biopsy not possible\n* Other hepatitis diagnoses\n* Failure to obtain consent\n* Unemancipated minors, people unable to express their consent\n* Non-affiliation to a social security or equivalent scheme,\n* Persons placed under judicial protection,\n* Person participating in another research including a period of exclusion still in progress.\n* Pregnant or breastfeeding women\n* De novo or old diagnosis (at the time of a flare-up)",{"count":81,"type":20},60,"Identify specific blood biomarkers for hepatitis induced by immune checkpoint inhibitors in comparison to idiopathic autoimmune hepatitis.",[26],[85,86,87,88],"proteomic analysis","blood biomarker","immune-mediated hepatitis secondary to immune checkpoint inhibitors","idiopathic autoimmune hepatitis","2025-11-20",{"date":91,"type":35},"2025-11-21",{"date":93,"type":35},"2024-07-17",{"date":95,"type":20},"2027-01-31",{"name":97,"class":42},"University Hospital, Montpellier",{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":106,"targetDuration":108,"studyType":53,"phases":4,"briefSummary":109,"conditions":110,"keywords":113,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":126},"100605802","management-of-immune-checkpoint-inhibition-related-hepatitis-using-low-dose-corticosteroids-100605802","NCT07167251","Management of Immune Checkpoint Inhibition-related Hepatitis Using Low-dose Corticosteroids","Management of Immune Checkpoint Inhibition-related Hepatitis Using Low-dose Corticosteroids - A Prospective Registry-based, Cohort Study","MIRA-HEP","Inclusion Criteria:\n\n1. Cancer patients aged 18 years or older\n2. Treatment with a programmed cell death protein 1 (PD-1) or programmed cell death ligand 1 (PD-L1) antibody, or a cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody, or a combination of a PD-1 and CTLA-4 antibody, or a PD-1 and lymphocyte-activation gene 3 (LAG-3) antibody\n3. Occurrence of immune-related hepatitis grade 2 to 3 (as per judgment of the investigator)\n4. Ability of the patient to comply with the study procedures (management of immune-related hepatitis)\n\nExclusion Criteria:\n\n1. Previous Immune-related hepatitis that required systemic therapy\n2. Treatment for Immune-related hepatitis has already been initiated with high-dose corticosteroids (\\>0.5 mg\u002Fkg body weight)\n3. Immune-related hepatitis with bilirubin \\> 1.5 ULN or clinical suspicion of cholangitis or elevated INR (beyond baseline)\n4. Immune-related hepatitis with grade 4 at first presentation\n5. Prior irAE treated with systemic immunosuppression\n6. Simultaneous immune-related neurological toxicity or immune-related myocarditis (since these usually have to be treated with high doses of corticosteroids)\n\n   a. Patients with other immune-related adverse events may be included according to the investigator's judgment\n7. Known liver disease (e.g., autoimmune hepatitis, active hepatitis B, C or E, hemochromatosis, liver cirrhosis Child-Pugh Score B or C, primary biliary cholangitis, primary biliary cirrhosis, Morbus Wilson)\n\n   a. Patients with liver metastasis are eligible\n8. Patients receiving cancer treatment other than immune checkpoint inhibitors in parallel (e.g., tyrosine kinase inhibitors or chemotherapy).\n\n   a. Patients who have received other cancer treatments in previous cycles are eligible, provided the treating physician does not assume any toxicity from the other medication.\n9. Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days prior to occurrence of IR hepatitis. Stable corticosteroid doses of \\\u003C 10mg prednisone equivalent are allowed.",{"count":107,"type":20},63,"6 Months","This study evaluates the effectiveness of low-dose corticosteroids in managing grade 2-3 immune-related hepatitis in cancer patients treated with immune checkpoint inhibitors. It aims to determine whether of 0.5-1miligram per kilogram bodyweight prednisolone is sufficient to manage immune-related hepatitis without the need for dose escalation or additional immunosuppressive therapy.",[111,56,112],"Immune Related Adverse Events","Cancer",[59,114,115,116],"Immune checkpoint inhibitor","Immune-related hepatitis","immune-mediated hepatitis","2025-09-08",{"date":119,"type":35},"2025-09-11",{"date":121,"type":35},"2025-08-25",{"date":123,"type":20},"2026-12-31",{"name":125,"class":42},"University Hospital, Basel, Switzerland",2,{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":4,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":134,"enrollmentInfo":135,"targetDuration":4,"studyType":21,"phases":136,"briefSummary":138,"conditions":139,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":71},"100476513","efficacy-and-safety-of-alss-treatment-for-icis-lf-in-patients-with-hcc-100476513","NCT05484908","Efficacy and Safety of ALSS Treatment for ICIs-LF in Patients With HCC","Efficacy and Safety of Artificial Liver Support System Treatment for Immune Checkpoint Inhibitors Related Liver Failure in Patients With Hepatocellular Carcinoma","Inclusion Criteria:\n\n1. Age from 18 to 65 years old;\n2. Clinical diagnosis of chronic hepatitis b virus infection (positive hepatitis b surface antigen or positive hepatitis b virus DNA \\> 0.5 year);\n3. Clinical diagnosis of hepatocellular carcinoma and receive immune checkpoint inhibitors treatment. The last treatment of immune checkpoint inhibitors is less than three months from inclusion;\n4. The level of hepatitis b virus DNA \\\u003C 2000 IU\u002FmL；\n5. Serum aspartate aminotransferase\u002Falanine aminotransferase \\> 20 times upper limit of normal；serum total bilirubin\\>10 times upper limit of normal；\n6. Prothrombin time international ratio \\> 1.5;\n7. Platelets \\> 50\\*10 E9\u002FL;\n8. Without intrahepatic bile duct dilation due to tumor progression.\n\nExclusion Criteria:\n\n1. Other active liver diseases;\n2. Other malignancy;\n3. Pregnancy or lactation;\n4. Human immunodeficiency virus infection or congenital immune deficiency diseases;\n5. Severe diabetes, autoimmune diseases; unstable infarction due to cardio-cerebrovascular events; other important organ dysfunctions or transplantation;\n6. Active bleeding, disseminated intravascular coagulation, thrombosis, or thrombotic disease;\n7. Patients received artificial liver support system treatment in one week before inclusion;\n8. Patients can not follow-up;\n9. Investigator considering inappropriate","65 Years",{"count":81,"type":20},[137],"NA","This study aims to investigate the efficacy and safety of artificial liver support system treatment for immune checkpoint inhibitors related liver failure in patients with hepatocellular carcinoma.",[56,140,141],"Liver Failure","Hepatocellular Carcinoma","2024-11-26",{"date":144,"type":35},"2024-11-29",{"date":146,"type":35},"2022-08-12",{"date":148,"type":20},"2024-12-31",{"name":150,"class":42},"Third Affiliated Hospital, Sun Yat-Sen University"]