[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100475628":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":23,"centralContacts":27,"locations":36,"responsibleParty":412,"collaborators":18,"id":414,"slug":415,"hasResults":416,"nctId":417,"briefTitle":418,"officialTitle":419,"acronym":420,"eligibilityCriteria":421,"healthyVolunteers":416,"sex":422,"minAge":423,"maxAge":424,"enrollmentInfo":425,"targetDuration":18,"studyType":428,"phases":429,"briefSummary":431,"conditions":432,"keywords":437,"overallStatus":441,"whyStopped":18,"lastUpdateSubmitDate":442,"lastUpdatePostDateStruct":443,"startDateStruct":446,"completionDateStruct":448,"leadSponsor":450,"locationsCount":451},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Corticosteroid therapy","EXPERIMENTAL","Prednisone or Prednisolone or Methylprednisolone : Patient with ASAIH will be treated in oral or intravenous (IV) with high doses ( ≥ 1mg\u002Fkg\u002Fday) of corticosteroids (Prednisone or Prednisolone or Methylprednisolone) until relapse (confirmed by blood tests and clinical status) requiring an emergency Liver Transplantation (LT) or death.",[13],"Other: Corticosteroid therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Patient without corticosteroid therapy","NO_INTERVENTION","Patient not treated will undergo to emergency Liver Transplantation (LT) or death.",null,[20],{"type":6,"name":9,"description":21,"armGroupLabels":22,"otherNames":18},"Administration of high doses of corticosteroids as early as possible. Patient non-responder to treatment should lead to listing for emergency liver transplantation (LT).",[9],[24],{"name":25,"affiliation":5,"role":26},"Eleonora DE MARTIN, MD, PhD","PRINCIPAL_INVESTIGATOR",[28,32],{"name":25,"role":29,"phone":30,"phoneExt":18,"email":31},"CONTACT","33 (0)1.45.59.64.33","eleonora.demartin@aphp.fr",{"name":33,"role":29,"phone":34,"phoneExt":18,"email":35},"Jean-Charles DUCLOS-VALLEE, MD, PhD","33 (0)1.45.59.64.28","jean-charles.duclos-vallee@aphp.fr",[37,55,69,84,98,113,128,143,157,172,187,198,213,228,243,258,273,285,296,311,326,341,356,370,385,400],{"facility":38,"status":18,"city":39,"state":18,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"CHU Angers, Service Hepato-gastro-enterologie","Angers","49933","France","FR",{"type":44,"coordinates":45},"Point",[46,47],-0.55202,47.47156,{"lat":47,"lon":46},[50,54],{"name":51,"role":29,"phone":52,"phoneExt":18,"email":53},"Adrien LANNES, MD","33 (0)2.41.35.31.42","adrien.lannes@chu-angers.fr",{"name":51,"role":26,"phone":18,"phoneExt":18,"email":18},{"facility":56,"status":18,"city":57,"state":18,"zip":58,"country":41,"countryCode":42,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"CHU Jean Minjoz Besançon, Service d'hepatologie et de soins intensifs digestifs","Besançon","25030",{"type":44,"coordinates":60},[61,62],6.01815,47.24878,{"lat":62,"lon":61},[65,68],{"name":66,"role":29,"phone":18,"phoneExt":18,"email":67},"Vincent DI MARTINO, MD","Vdimartino@chu-besancon.fr",{"name":66,"role":26,"phone":18,"phoneExt":18,"email":18},{"facility":70,"status":18,"city":71,"state":18,"zip":72,"country":41,"countryCode":42,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"APHP, Hopital Avicenne, Service Hepatologie et Oncologie Hépatique","Bobigny","93000",{"type":44,"coordinates":74},[75,76],2.45012,48.90982,{"lat":76,"lon":75},[79,83],{"name":80,"role":29,"phone":81,"phoneExt":18,"email":82},"Nathalie GANNE, MD","33 (0)1.48.02.66.66","nathalie.ganne@aphp.fr",{"name":80,"role":26,"phone":18,"phoneExt":18,"email":18},{"facility":85,"status":18,"city":86,"state":18,"zip":87,"country":41,"countryCode":42,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"CHU Brest, Hopital de la Cavale Blanche Service Gastro-enterologie","Brest","29609",{"type":44,"coordinates":89},[90,91],-4.48628,48.39029,{"lat":91,"lon":90},[94,97],{"name":95,"role":29,"phone":18,"phoneExt":18,"email":96},"Noemi REBOUX, MD","noemi.reboux@chu-brest.fr",{"name":95,"role":26,"phone":18,"phoneExt":18,"email":18},{"facility":99,"status":18,"city":100,"state":18,"zip":101,"country":41,"countryCode":42,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"CHU de Caen, Hopital de la Cote de Nacre, Service Hepato-Gastro-Enterologie et Nutrition","Caen","14033",{"type":44,"coordinates":103},[104,105],-0.35912,49.18585,{"lat":105,"lon":104},[108,112],{"name":109,"role":29,"phone":110,"phoneExt":18,"email":111},"Isabelle OLLIVIER-HOURMAND, MD","33 (0)2.31.06.45.44","ollivierhourmand-i@chu-caen.fr",{"name":109,"role":26,"phone":18,"phoneExt":18,"email":18},{"facility":114,"status":18,"city":115,"state":18,"zip":116,"country":41,"countryCode":42,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"CHU Trousseau Chambray, Service Gastro-enterologie et hepatologie","Chambray-lès-Tours","37170",{"type":44,"coordinates":118},[119,120],0.70286,47.33537,{"lat":120,"lon":119},[123,127],{"name":124,"role":29,"phone":125,"phoneExt":18,"email":126},"Helene BARRAUD, MD","33 (0)2.47.47.59.16","h.barraud@chu-tours.fr",{"name":124,"role":26,"phone":18,"phoneExt":18,"email":18},{"facility":129,"status":18,"city":130,"state":18,"zip":131,"country":41,"countryCode":42,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"CHU Dijon, Service Hepato-gastroenterologie et cancerologie digestive","Dijon","21079",{"type":44,"coordinates":133},[134,135],5.01391,47.31344,{"lat":135,"lon":134},[138,142],{"name":139,"role":29,"phone":140,"phoneExt":18,"email":141},"Anne MINELLO, MD","33 (0)3.80.29.37.50","anne.minello@chu-dijon.fr",{"name":139,"role":26,"phone":18,"phoneExt":18,"email":18},{"facility":144,"status":18,"city":145,"state":18,"zip":146,"country":41,"countryCode":42,"cosmosGeoPoint":147,"geoPoint":151,"contacts":152},"CHRU de Lille, Hopital Claude Huriez, Service des maladies de l'appareil digestif et de la nutrition","Lille","59037",{"type":44,"coordinates":148},[149,150],3.05512,50.63391,{"lat":150,"lon":149},[153,156],{"name":154,"role":29,"phone":18,"phoneExt":18,"email":155},"Alexandre LOUVET, MD","alexandre.louvet@chru-lille.fr",{"name":154,"role":26,"phone":18,"phoneExt":18,"email":18},{"facility":158,"status":18,"city":159,"state":18,"zip":160,"country":41,"countryCode":42,"cosmosGeoPoint":161,"geoPoint":165,"contacts":166},"CHU Limoges, Hopital Dupuytren, Service Hepato-gastroenterologie et nutrition","Limoges","87042",{"type":44,"coordinates":162},[163,164],1.24759,45.83362,{"lat":164,"lon":163},[167,171],{"name":168,"role":29,"phone":169,"phoneExt":18,"email":170},"Marilyne DEBETTE-GRATIEN, MD","33 (0)5.55.05.66.21","marilyne.gratien@chu-limoges.fr",{"name":168,"role":26,"phone":18,"phoneExt":18,"email":18},{"facility":173,"status":18,"city":174,"state":18,"zip":175,"country":41,"countryCode":42,"cosmosGeoPoint":176,"geoPoint":180,"contacts":181},"CHU Hopital Edouard Herriot, Service Hepato-gastro-enterologie","Lyon","69003",{"type":44,"coordinates":177},[178,179],4.84789,45.74906,{"lat":179,"lon":178},[182,186],{"name":183,"role":29,"phone":184,"phoneExt":18,"email":185},"Jerome DUMORTIER, MD","33 (0)4.72.11.01.09","jerome.dumortier@chu-lyon.fr",{"name":183,"role":26,"phone":18,"phoneExt":18,"email":18},{"facility":188,"status":18,"city":174,"state":18,"zip":189,"country":41,"countryCode":42,"cosmosGeoPoint":190,"geoPoint":192,"contacts":193},"CHU Lyon, Hopital Croix Rousse, Service Hepato-gastro-enterologie","69317",{"type":44,"coordinates":191},[178,179],{"lat":179,"lon":178},[194,197],{"name":195,"role":29,"phone":18,"phoneExt":18,"email":196},"Teresa Maria ANTONINI-MICHELLE, MD","teresa.antonini@chu-lyon.fr",{"name":195,"role":26,"phone":18,"phoneExt":18,"email":18},{"facility":199,"status":18,"city":200,"state":18,"zip":201,"country":41,"countryCode":42,"cosmosGeoPoint":202,"geoPoint":206,"contacts":207},"Hopital Saint Joseph, Service Hepato-gastro-enterologie","Marseille","13285",{"type":44,"coordinates":203},[204,205],5.38107,43.29695,{"lat":205,"lon":204},[208,212],{"name":209,"role":29,"phone":210,"phoneExt":18,"email":211},"Olivia PIETRI, MD","33 (0)4 91 80 70 61","opietri@hopital-saint-joseph.fr",{"name":209,"role":26,"phone":18,"phoneExt":18,"email":18},{"facility":214,"status":18,"city":215,"state":18,"zip":216,"country":41,"countryCode":42,"cosmosGeoPoint":217,"geoPoint":221,"contacts":222},"CHU Montpellier, Hopital Saint Eloi, Service Hepato-gastro-enterologie","Montpellier","34295",{"type":44,"coordinates":218},[219,220],3.87635,43.61093,{"lat":220,"lon":219},[223,227],{"name":224,"role":29,"phone":225,"phoneExt":18,"email":226},"Lucy MEUNIER, MD","33 (0)4.67.33.66.33","lucy.meunier@chu-montpellier.fr",{"name":224,"role":26,"phone":18,"phoneExt":18,"email":18},{"facility":229,"status":18,"city":230,"state":18,"zip":231,"country":41,"countryCode":42,"cosmosGeoPoint":232,"geoPoint":236,"contacts":237},"CHU Nice, Hopital de l'Archet 2, Service Hepatologie","Nice","06200",{"type":44,"coordinates":233},[234,235],7.26608,43.70313,{"lat":235,"lon":234},[238,242],{"name":239,"role":29,"phone":240,"phoneExt":18,"email":241},"Rodolphe ANTY, MD","33 (0)4.92.03.63.85","anty.r@chu-nice.fr",{"name":239,"role":26,"phone":18,"phoneExt":18,"email":18},{"facility":244,"status":18,"city":245,"state":18,"zip":246,"country":41,"countryCode":42,"cosmosGeoPoint":247,"geoPoint":251,"contacts":252},"CHU Orleans, Hopital de la Source, Service Gastro-enterologie et hepatologie","Orléans","45100",{"type":44,"coordinates":248},[249,250],1.90407,47.90248,{"lat":250,"lon":249},[253,257],{"name":254,"role":29,"phone":255,"phoneExt":18,"email":256},"Pascal POTIER, MD","33 (0)2.38.22.96.43","pascal.potier@chr-orleans.fr",{"name":254,"role":26,"phone":18,"phoneExt":18,"email":18},{"facility":259,"status":18,"city":260,"state":18,"zip":261,"country":41,"countryCode":42,"cosmosGeoPoint":262,"geoPoint":266,"contacts":267},"AP-HP, Hopital St Antoine, Service Hepato-gastro-enterologie","Paris","75012",{"type":44,"coordinates":263},[264,265],2.3488,48.85341,{"lat":265,"lon":264},[268,272],{"name":269,"role":29,"phone":270,"phoneExt":18,"email":271},"Olivier CHAZOULLIERES, MD","33 (0)1.49.28.29.23","olivier.chazouilleres@aphp.fr",{"name":269,"role":26,"phone":18,"phoneExt":18,"email":18},{"facility":274,"status":18,"city":260,"state":18,"zip":275,"country":41,"countryCode":42,"cosmosGeoPoint":276,"geoPoint":278,"contacts":279},"APHP, Hopital Pitie-Salpetriere, Service d'hepatologie et de gastroenterologie","75013",{"type":44,"coordinates":277},[264,265],{"lat":265,"lon":264},[280,284],{"name":281,"role":29,"phone":282,"phoneExt":18,"email":283},"Marika RUDLER, MD","33 (0)1.42.17.56.91","Marika.rudler@aphp.fr",{"name":281,"role":26,"phone":18,"phoneExt":18,"email":18},{"facility":286,"status":18,"city":260,"state":18,"zip":287,"country":41,"countryCode":42,"cosmosGeoPoint":288,"geoPoint":290,"contacts":291},"AP-HP, Hopital Cochin Service Hepatologie","75014",{"type":44,"coordinates":289},[264,265],{"lat":265,"lon":264},[292,295],{"name":293,"role":29,"phone":18,"phoneExt":18,"email":294},"Charlotte MOULIADE, MD","charlotte.mouliade@aphp.fr",{"name":293,"role":26,"phone":18,"phoneExt":18,"email":18},{"facility":297,"status":18,"city":298,"state":18,"zip":299,"country":41,"countryCode":42,"cosmosGeoPoint":300,"geoPoint":304,"contacts":305},"CHU Bordeaux, GH Sud Haut-Leveque, Service Hepato-gastro-enterologie","Pessac","33604",{"type":44,"coordinates":301},[302,303],-0.6324,44.80565,{"lat":303,"lon":302},[306,310],{"name":307,"role":29,"phone":308,"phoneExt":18,"email":309},"Victor DE LEDINGHEN, MD","33 (0)5.57.65.64.39","victor.deledinghen@chu-bordeaux.fr",{"name":307,"role":26,"phone":18,"phoneExt":18,"email":18},{"facility":312,"status":18,"city":313,"state":18,"zip":314,"country":41,"countryCode":42,"cosmosGeoPoint":315,"geoPoint":319,"contacts":320},"CHU La Miletrie, Service Hepato-gastro-enterologie","Poitiers","86000",{"type":44,"coordinates":316},[317,318],0.34348,46.58261,{"lat":318,"lon":317},[321,325],{"name":322,"role":29,"phone":323,"phoneExt":18,"email":324},"Christine SILVAIN, MD","33 (0)5.49.44.44.38","c.silvain@chu-poitiers.fr",{"name":322,"role":26,"phone":18,"phoneExt":18,"email":18},{"facility":327,"status":18,"city":328,"state":18,"zip":329,"country":41,"countryCode":42,"cosmosGeoPoint":330,"geoPoint":334,"contacts":335},"CHU Reims, Hopital Robert Debré, Service Hepato-Gastroenterologie et de Cancerologie digestive","Reims","51092",{"type":44,"coordinates":331},[332,333],4.02853,49.26526,{"lat":333,"lon":332},[336,340],{"name":337,"role":29,"phone":338,"phoneExt":18,"email":339},"Alexandra HEURGUE-BERLOT, MD","33 (0)3.26.78.78.78","aheurgue@chu-reims.fr",{"name":337,"role":26,"phone":18,"phoneExt":18,"email":18},{"facility":342,"status":18,"city":343,"state":18,"zip":344,"country":41,"countryCode":42,"cosmosGeoPoint":345,"geoPoint":349,"contacts":350},"CHU de Rennes, Hopital de Pontchaillou, Service Maladie du foie","Rennes","35000",{"type":44,"coordinates":346},[347,348],-1.67431,48.11109,{"lat":348,"lon":347},[351,355],{"name":352,"role":29,"phone":353,"phoneExt":18,"email":354},"Pauline HOUSSEL-DEBRY, MD","33 (0).99.28.42.98","pauline.houssel-debry@chu-rennes.fr",{"name":352,"role":26,"phone":18,"phoneExt":18,"email":18},{"facility":357,"status":18,"city":358,"state":18,"zip":359,"country":41,"countryCode":42,"cosmosGeoPoint":360,"geoPoint":364,"contacts":365},"CHU Rouen, Service d'hepatogastro-enterologie","Rouen","76031",{"type":44,"coordinates":361},[362,363],1.09932,49.44313,{"lat":363,"lon":362},[366,369],{"name":367,"role":29,"phone":18,"phoneExt":18,"email":368},"Odile GORIA, MD","Odile.Goria@chu-rouen.fr",{"name":367,"role":26,"phone":18,"phoneExt":18,"email":18},{"facility":371,"status":18,"city":372,"state":18,"zip":373,"country":41,"countryCode":42,"cosmosGeoPoint":374,"geoPoint":378,"contacts":379},"CHU Strasbourg, Hopital de Hautepierre, Service Hepato-gastro-enterologie","Strasbourg","67200",{"type":44,"coordinates":375},[376,377],7.74553,48.58392,{"lat":377,"lon":376},[380,384],{"name":381,"role":29,"phone":382,"phoneExt":18,"email":383},"Camille BESCH, MD","33 (0)3.88.12.74.48","camille.besch@chru-strasbourg.fr",{"name":381,"role":26,"phone":18,"phoneExt":18,"email":18},{"facility":386,"status":18,"city":387,"state":18,"zip":388,"country":41,"countryCode":42,"cosmosGeoPoint":389,"geoPoint":393,"contacts":394},"CHU Toulouse, Hopital Rangueil, Service Hepatologie","Toulouse","31059",{"type":44,"coordinates":390},[391,392],1.44367,43.60426,{"lat":392,"lon":391},[395,399],{"name":396,"role":29,"phone":397,"phoneExt":18,"email":398},"Christophe BUREAU, MD","33 (0)5.61.77.25.27","bureau.c@chu-toulouse.fr",{"name":396,"role":26,"phone":18,"phoneExt":18,"email":18},{"facility":401,"status":18,"city":402,"state":18,"zip":403,"country":41,"countryCode":42,"cosmosGeoPoint":404,"geoPoint":408,"contacts":409},"AP-HP, Paul Brousse Hospital, Centre Hepato-Biliaire","Villejuif","94800",{"type":44,"coordinates":405},[406,407],2.35992,48.7939,{"lat":407,"lon":406},[410,411],{"name":25,"role":29,"phone":30,"phoneExt":18,"email":31},{"name":25,"role":26,"phone":18,"phoneExt":18,"email":18},{"type":413,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100475628","validation-of-a-prognostic-score-for-steroid-therapy-response-in-acute-severe-autoimmune-hepatitis-100475628",false,"NCT05473403","Validation of a Prognostic Score for Steroid Therapy Response in Acute Severe Autoimmune Hepatitis","Validation of a Prognostic Score for Steroid Therapy Response in Acute Severe Autoimmune Hepatitis, a National Prospective Multicentre Study","PRO-SURFASA","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Strong clinical suspicion of severe acute autoimmune hepatitis defined by the presence of increased IgG and\u002For autoantibodies and\u002For histology characteristic of the disease in the absence of other causes of severe acute hepatitis.\n* International Normalized Ratio (INR) ≥ 1.5\n* Informed, written consent\n* Patient having the rights to French social insurance\n\nExclusion Criteria:\n\n* Previous medical history of chronic liver disease including autoimmune liver disease (AIH, Primary Biliary Cholangitis (PBC), Primary Sclerosing Cholangitis (PSC) , alcoholic hepatitis etc.)\n* Other causes of acute severe hepatitis:\n\n  * Hepatitis A Virus (HAV) hepatitis, defined by HAV Immunoglobulin M (IgM) antibodies\n  * Hepatitis B Virus (HBV) hepatitis, defined by HBs antigen and HBV IgM antibodies\n  * Hepatitis E Virus (HEV) hepatitis, defined by HEV IgM antibodies or positive HEV-RNA in immunosuppressed patients\n  * Drug induced hepatitis, histologically proved or induced by well-known hepatotoxic substances\n  * Acute hypoxemic hepatitis, context of shock, hypoxemia or heat shock\n  * Budd-Chiari syndrome, diagnosed by imagery (Doppler ultrasound, CT scan)\n  * Acute hepatitis in the context of a HELLP (Hemolysis, Elevated Liver enzymes and a Low Platelet count) syndrome or acute fatty liver of pregnancy\n* Use of corticosteroids 1 month before inclusion\n* Pregnant or lactating woman\n* Curator or guardianship or patient placed under judicial protection\n* Participation in other interventional research during the study","ALL","18 Years","99 Years",{"count":426,"type":427},150,"ESTIMATED","INTERVENTIONAL",[430],"NA","Autoimmune hepatitis (AIH) is a chronic liver disease, which is characterized by the increase of immunoglobulin G (IgG) level, the presence of auto-antibodies and a typical histology, in the absence of other liver disease.\n\nDue to the heterogeneity of AIH manifestations, different scoring systems have been validated in order to make a reliable diagnosis. The two most recent scoring systems are: the revised International Autoimmune Hepatitis Group (IAIHG) criteria and the IAIHG simplified criteria. The second one is recommended by the European Association for the Study of the Liver (EASL) clinical practice guidelines (CPGs).\n\nThe EASL clinical practice guidelines suggests that the treatment of ASAIH (Acute Severe AIH) is high doses of corticosteroids (superior to 1mg\u002Fkg\u002Fday) as early as possible and a lack of improvement within seven days should lead to listing for emergency liver transplantation (LT). However, the \"lack of improvement\" is not objectively defined and the grading of recommendation is III (Opinions of respected authorities).\n\nThe hypothesis of the study is that the previously developed decisional score on a retrospective series will prospectively allow the differentiation between patients with ASAIH (Acute Severe AIH) who respond to corticosteroid therapy and should be maintained on treatment and patients who do not respond and should be rapidly evaluated for LT. The score will be computed at day 3 since corticosteroid introduction.",[433,434,435,436],"Liver Failure, Acute","Hepatitis, Autoimmune","Organ Dysfunction Scores","Risk Factors",[438,439,440],"Acute Severe AutoImmune Hepatitis (ASAIH)","Decisional score","Prognostic score","NOT_YET_RECRUITING","2024-03-11",{"date":444,"type":445},"2024-03-13","ACTUAL",{"date":447,"type":427},"2024-06-01",{"date":449,"type":427},"2028-06-30",{"name":5,"class":6},26]