[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100501532":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":26,"centralContacts":32,"locations":39,"responsibleParty":147,"collaborators":10,"id":150,"slug":151,"hasResults":152,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":156,"eligibilityCriteria":157,"healthyVolunteers":152,"sex":158,"minAge":10,"maxAge":10,"enrollmentInfo":159,"targetDuration":10,"studyType":162,"phases":10,"briefSummary":163,"conditions":164,"keywords":10,"overallStatus":42,"whyStopped":10,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":175},{"fullName":5,"class":6},"Hannover Medical School","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Autoimmune Hepatitis",null,"This group includes patients with a diagnosis of Autoimmune Hepatitis according to the simplified diagnostic criteria by Hennes et al. made by the local treating physician. The diagnosis of autoimmune hepatitis additionally requires steroid dependency \\> six months for this study to discriminate Autoimmune Hepatitis from autoimmune like drug-induced liver injury (DILI) which are hard to discriminate at diagnosis and with the latter often being treating with a short course of corticosteroids less than six months. One serum sample will be stored for anonymized evaluation of serum autoantibodies",[13],"Diagnostic Test: polyreactive immunoglobulin G",{"label":15,"type":10,"description":16,"interventionNames":17},"non-autoimmune hepatitis liver disease","This group includes patients with a diagnosis of any non-viral liver disease that is not autoimmune hepatitis and whose diagnosis necessitated a diagnostic liver biopsy in the work-up of the liver disease for local care. One serum sample will be stored for anonymized evaluation of serum autoantibodies",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DIAGNOSTIC_TEST","polyreactive immunoglobulin G","Polyreactive immunoglobulin G will be tested centralized in Hannover as published (Taubert, Engel et al., Hepatology, 2022). The current standard diagnostic autoantibodies (e.g. ANA, anti-SMA, anti-LKM, anti-LC1, anti-SLA\u002FL) will be tested centrally in Hannover according to current guidelines.",[9,15],[25],"Conventional diagnostic autoantibodies",[27,30],{"name":28,"affiliation":5,"role":29},"Bastian Engel, Dr.","PRINCIPAL_INVESTIGATOR",{"name":31,"affiliation":5,"role":29},"Richard Taubert, Dr.",[33,37],{"name":28,"role":34,"phone":35,"phoneExt":10,"email":36},"CONTACT","+49 511 532 6766","Engel.Bastian@mh-hannover.de",{"name":31,"role":34,"phone":35,"phoneExt":10,"email":38},"Taubert.Richard@mh-hannover.de",[40,58,69,81,97,111,123,135],{"facility":41,"status":42,"city":43,"state":10,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"University Medical Centre Aachen","RECRUITING","Aachen","52074","Germany","DE",{"type":48,"coordinates":49},"Point",[50,51],6.08342,50.77664,{"lat":51,"lon":50},[54,56],{"name":55,"role":34,"phone":10,"phoneExt":10,"email":10},"Tony Bruns, MD, Prof.",{"name":57,"role":34,"phone":10,"phoneExt":10,"email":10},"Karsten Grosse, MD",{"facility":59,"status":42,"city":60,"state":10,"zip":10,"country":45,"countryCode":46,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"University Hospital Bonn","Bonn",{"type":48,"coordinates":62},[63,64],7.09549,50.73438,{"lat":64,"lon":63},[67],{"name":68,"role":34,"phone":10,"phoneExt":10,"email":10},"Leona Dold, MD",{"facility":70,"status":42,"city":71,"state":10,"zip":72,"country":45,"countryCode":46,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"University Medical Center Hamburg-Eppendorf","Hamburg","20251",{"type":48,"coordinates":74},[75,76],9.99302,53.55073,{"lat":76,"lon":75},[79],{"name":80,"role":34,"phone":10,"phoneExt":10,"email":10},"Marcial Sebode, MD",{"facility":5,"status":42,"city":82,"state":10,"zip":83,"country":45,"countryCode":46,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"Hanover","30625",{"type":48,"coordinates":85},[86,87],9.73322,52.37052,{"lat":87,"lon":86},[90,93,95],{"name":91,"role":34,"phone":92,"phoneExt":10,"email":36},"Bastian Engel, MD","+495115326766",{"name":94,"role":34,"phone":92,"phoneExt":10,"email":38},"Richard Taubert, MD",{"name":96,"role":34,"phone":10,"phoneExt":10,"email":10},"Norman Junge, MD",{"facility":98,"status":42,"city":99,"state":10,"zip":100,"country":45,"countryCode":46,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"University Medical Center Heidelberg","Heidelberg","69120",{"type":48,"coordinates":102},[103,104],8.69079,49.40768,{"lat":104,"lon":103},[107,109],{"name":108,"role":34,"phone":10,"phoneExt":10,"email":10},"Uta Merle, MD, Prof.",{"name":110,"role":34,"phone":10,"phoneExt":10,"email":10},"Jessica Seessle, MD",{"facility":112,"status":42,"city":113,"state":10,"zip":114,"country":45,"countryCode":46,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"University Hospital Schleswig-Holstein, Location Lübeck","Lübeck","23562",{"type":48,"coordinates":116},[117,118],10.68729,53.86893,{"lat":118,"lon":117},[121],{"name":122,"role":34,"phone":10,"phoneExt":10,"email":10},"Henrike Dobbermann, MD",{"facility":124,"status":42,"city":125,"state":10,"zip":126,"country":45,"countryCode":46,"cosmosGeoPoint":127,"geoPoint":131,"contacts":132},"University Hospital Magdeburg","Magdeburg","39120",{"type":48,"coordinates":128},[129,130],11.63189,52.13129,{"lat":130,"lon":129},[133],{"name":134,"role":34,"phone":10,"phoneExt":10,"email":10},"Verena Keitel-Anselmino, MD, Prof.",{"facility":136,"status":42,"city":137,"state":10,"zip":138,"country":45,"countryCode":46,"cosmosGeoPoint":139,"geoPoint":143,"contacts":144},"Rostock University Medical Centre","Rostock","18057",{"type":48,"coordinates":140},[141,142],12.14049,54.0887,{"lat":142,"lon":141},[145],{"name":146,"role":34,"phone":10,"phoneExt":10,"email":10},"Theresia Blattmann, MD",{"type":29,"investigatorFullName":148,"investigatorTitle":149,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Engel, Bastian Dr.","Principal Investigator","100501532","predicting-steroid-dependent-liver-injury-with-polyreactive-immunoglobulin-g-100501532",false,"NCT05810480","PredIcting SterOid DepeNdEnt LivEr InjuRy with Polyreactive Immunoglobulin G","Prospective Multicenter Study: PredIcting SterOid DepeNdEnt LivEr Injury (PIONEER) with Polyreactive Immunoglobulin G","PIONEER","Inclusion Criteria:\n\n* Diagnostic liver biopsy for the work-up of any liver disease\n* Informed consent\n* Definition of any liver disease according to current societal guidelines\n\nExclusion Criteria:\n\n* No ongoing immunosuppression at the liver biopsy or prior to the liver biopsy\n* Liver biopsies for the grading or staging of an already known liver disease (e.g. non-alcoholic fatty liver disease (NAFLD), Hepatitis B\u002FD Virus Infections (HBV\u002FHDV Infection), …)","ALL",{"count":160,"type":161},200,"ESTIMATED","OBSERVATIONAL","The investigators identified polyreactive immunoglobulin G (pIgG) in adults (published in Hepatology: https:\u002F\u002Fdoi.org\u002F10.1002\u002Fhep.32134) and children (in preparation). Quantification of these pIgG using a \"home-made\" ELISA facilitates the diagnosis of autoimmune hepatitis (AIH) as compared to non-AIH liver diseases and healthy controls. Positivity for pIgG was independent from ANA\u002FSMA positivity and equally diagnostic for AIH even when conventional autoantibodies (ANA\u002FSMA\u002FSLA\u002FLKM) were negative.\n\nAdditionally, the frequency of pIgG was lower than conventional autoantibodies (ANA, SMA) in vaccinia\u002Fdrug associated severe liver injury in a retrospective multicenter study after Covid-19 vaccination (https:\u002F\u002Fdoi.org\u002F10.1016\u002Fj.jhepr.2022.100605).\n\nAims of the study The study aims to evaluate the diagnostic capacity of pIgG to predict AIH in comparison to other liver diseases prospectively. To avoid diagnostic inaccuracy between AIH with long-term need for an immunosuppression and drug induced liver injury with autoimmune features, which can be indistinguishable from AIH at baseline and which has a very low relapse rate after a short steroid course, a follow-up after six months is obligatory for inclusion.\n\nTherefore, the investigators will collect one serum sample from every patient (without immunosuppressive treatment) that presents to the respective hospital for evaluation of liver disease by liver biopsy within one year after initiation of the study and that provided written informed consent. Follow-up for evaluation of steroid dependency at six months after diagnosis is obligatory.",[9,165],"Autoimmune Liver Disease","2024-10-14",{"date":168,"type":169},"2024-10-16","ACTUAL",{"date":171,"type":169},"2023-06-06",{"date":173,"type":161},"2027-01",{"name":5,"class":6},8]