[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100574586":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":25,"studyPopulation":26,"armGroups":27,"interventions":33,"overallOfficials":38,"centralContacts":43,"locations":53,"responsibleParty":92,"collaborators":21,"id":94,"slug":21,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":95,"sex":101,"minAge":102,"maxAge":21,"enrollmentInfo":103,"targetDuration":21,"studyType":106,"phases":21,"briefSummary":107,"conditions":108,"keywords":110,"overallStatus":75,"whyStopped":21,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Centre Hospitalier Universitaire de la Guadeloupe","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":21},[9],{"measure":10,"description":11,"timeFrame":12},"histological rereading of seronegative AIH","Percentage comparisons will be made by a chi-2 test or a Fischer test.","Baseline",[14,18],{"measure":15,"description":16,"timeFrame":17},"assessment of the severity of the disease","\\- Number of corticosteroid HAI defined by the maintenance of corticosteroid therapy\\> 20mg \u002F d beyond 6 months of treatment - Number of corticosteroid-resistant AIH. Percentage comparisons will be made by a chi-2 test or a Fischer test.","6 months, 12 months",{"measure":19,"description":19,"timeFrame":20},"Constitution of a serotheque in order to search for other autoAb described as correlated to the severity of the AIH.","At inclusion",null,{"allocation":21,"interventionModel":21,"interventionModelDescription":21,"primaryPurpose":21,"observationalModel":23,"timePerspective":24,"maskingInfo":21},"COHORT","PROSPECTIVE","Evaluate the proportion of seronegative auto-immune hepatitis and a possible relationship with the severity of the disease. Criteria of severity will be defined by corticodependance, corticoresistance and a severe form of the disease at diagnosis (cirrhosis or fulminant hepatitis). In case of predominant seronegative forms, other auto-antibodies related to this auto-immue hepatitis will be searched.\n\nPatients from the Guadeloupean constitutive center of rare diseases (CCRD Filfoie) and from the Saint-Antoine hospital will be retrospectively analyzed, and new patients will be prospectively followed.","only acute or chronic AIH patients will be included in the study.",[28],{"label":29,"type":21,"description":30,"interventionNames":31},"acute or chronic Auto-Immune Hepatitis patients","For the study, a blood sample will be collected from the patient in order to build up a serological library which allow the search for rare autoAb whose interest has been demonstrated as prognostic factors of the disease",[32],"Other: blood sampling",[34],{"type":6,"name":35,"description":36,"armGroupLabels":37,"otherNames":21},"blood sampling","For the study, a blood sample will be collected from the patient in order to do build up a serological library which will allow the search for rare autoAb whose interest has been demonstrated as prognostic factors of the disease.",[29],[39],{"name":40,"affiliation":41,"role":42},"Moana Lemoinne, doctor","chu de pointe à pitre","PRINCIPAL_INVESTIGATOR",[44,49],{"name":45,"role":46,"phone":47,"phoneExt":21,"email":48},"Valérie SOTER, Promotion Unit manager","CONTACT","+590 590 934677","valerie.soter@chu-guadeloupe.fr",{"name":50,"role":46,"phone":51,"phoneExt":21,"email":52},"Eunice NUBRET, Project manager","+590 0590934686","eunice.nubret@chu-guadeloupe.fr",[54,73],{"facility":55,"status":56,"city":57,"state":58,"zip":59,"country":58,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Hospital of Saint-Antoine","NOT_YET_RECRUITING","Paris","France","75012","FR",{"type":62,"coordinates":63},"Point",[64,65],2.3488,48.85341,{"lat":65,"lon":64},[68,71],{"name":69,"role":46,"phone":21,"phoneExt":21,"email":70},"Sara Lemoinne, doctor","sara.lemoinne@aphp.fr",{"name":72,"role":46,"phone":21,"phoneExt":21,"email":21},"Sara LEMOINNE, Doctor",{"facility":74,"status":75,"city":76,"state":77,"zip":78,"country":58,"countryCode":60,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"CHU de Pointe-à Pitre","RECRUITING","Pointe à Pitre","Guadeloupe","97159",{"type":62,"coordinates":80},[81,82],1.98937,44.07984,{"lat":82,"lon":81},[85,89,90],{"name":86,"role":46,"phone":87,"phoneExt":21,"email":88},"Moana GELU-SIMEON, medecine degree,","+590 0590891446","moana.simeon@chu-guadeloupe.fr",{"name":21,"role":46,"phone":21,"phoneExt":21,"email":52},{"name":91,"role":46,"phone":21,"phoneExt":21,"email":21},"Moana GELU-SIMEON, Doctor",{"type":93,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100574586",false,"NCT06761209","Is Negativity of Autoantibodies a Marker of Severity in Auto-immune Hepatitis?","Is Negativity of Autoantibodies a Marker of Severity in Auto-immune Hepatitis","HAI-NEG","Inclusion Criteria:\n\n* \\- Any patient over 18 years old\n* Patient followed at Hôpital Saint-Antoine or treated for HAI or in Guadeloupe within the framework of the CCRD Filfoie for an acute or chronic AIH under immunosuppressive treatment\n* Patient affiliate or beneficiary of a social security scheme\n* Free, informed and written consent signed by the patient and the investigator\n\n  o exclusion criteria: - Patient under 18 years old\n* Patient not able to give his\u002Fher consent\n* Viral hepatitis: viruses A to E, Epstein-Barr virus, cytomegalovirus and herpes simplex virus\n* Isolated primary biliary cholangitis\n* Isolated primary sclerosing cholangitis\n* Drug-induced liver injury\n* Wilson disease\n* Alcoholic hepatitis\n* Hemochromatosis\n* Sickle cell disease and heart liver\n* Non-alcoholic steato-hepatitis","ALL","18 Years",{"count":104,"type":105},100,"ESTIMATED","OBSERVATIONAL","Evaluate the proportion of seronegative auto-immune hepatitis and a possible relationship with the severity of the disease. Criteria of severity will be defined by corticodependance, corticoresistance and a severe form of the disease at diagnosis (cirrhosis or fulminant hepatitis). In case of predominant seronegative forms, other auto-antibodies related to this auto-immue hepatitis will be searched.",[109],"Auto-immune Hepatitis",[111,112,113,114],"autoantibodies","auto-immune hepatitis","prognosis","afrocaribbean population","2024-12-30",{"date":117,"type":118},"2025-01-07","ACTUAL",{"date":120,"type":118},"2022-07-01",{"date":122,"type":105},"2026-12",{"name":5,"class":6},2]