[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100552277":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":34,"locations":42,"responsibleParty":59,"collaborators":10,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":70,"maxAge":10,"enrollmentInfo":71,"targetDuration":10,"studyType":74,"phases":10,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":45,"whyStopped":10,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"University Hospital, Montpellier","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"CHILI : hepatitis induced by immune checkpoint inhibitors",null,"Patient with immunotherapy-induced hepatitis",[13,14],"Biological: Blood sample collection","Procedure: Liver biopsy",{"label":16,"type":10,"description":17,"interventionNames":18},"Control group: idiopathic autoimmune hepatitis","Patient with idiopathic autoimmune hepatitis",[13,14],[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"BIOLOGICAL","Blood sample collection","6 collections of 5mL blood samples as part of usual care (pre-inclusion visit at Day-7, inclusion visit at Day 0, visit1 at Day 14, visit2 at Day 28, visit3 at Day 90, visit4 at 6 months) and 5 blood sample collections of 5 mL for proteomic analysis in the context of research (inclusion visit at Day 0, visit1 at Day 14, visit2 at Day 28, visit3 at Day 90, visit4 at 6 months)",[9,16],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":10},"PROCEDURE","Liver biopsy","1 liver biopsy performed as part of routine care and 1 additional sample for research: transparietal needle biopsy under ultrasound identification under local anesthesia by a radiologist, 1 to 2 cm per core taken, 2 cores are taken.",[9,16],[31],{"name":32,"affiliation":5,"role":33},"Lucy MEUNIER, MD","STUDY_DIRECTOR",[35,39],{"name":32,"role":36,"phone":37,"phoneExt":10,"email":38},"CONTACT","0467330224","lucy-meunier@chu-montpellier.fr",{"name":40,"role":36,"phone":10,"phoneExt":10,"email":41},"Lina HOUNTONDJI, MD","l-hountondji@chu-montpellier.fr",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":47,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"CHU de Montpellier","RECRUITING","Montpellier","France","34295","FR",{"type":51,"coordinates":52},"Point",[53,54],3.87635,43.61093,{"lat":54,"lon":53},[57],{"name":32,"role":58,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"type":60,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100552277","specific-biomarkers-of-immune-mediated-hepatitis-secondary-to-immune-checkpoint-inhibitors-100552277",false,"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)","ALL","18 Years",{"count":72,"type":73},60,"ESTIMATED","OBSERVATIONAL","Identify specific blood biomarkers for hepatitis induced by immune checkpoint inhibitors in comparison to idiopathic autoimmune hepatitis.",[77],"Immune-mediated Hepatitis",[79,80,81,82],"proteomic analysis","blood biomarker","immune-mediated hepatitis secondary to immune checkpoint inhibitors","idiopathic autoimmune hepatitis","2025-11-20",{"date":85,"type":86},"2025-11-21","ACTUAL",{"date":88,"type":86},"2024-07-17",{"date":90,"type":73},"2027-01-31",{"name":5,"class":6},1]