[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586998":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":78,"centralContacts":101,"locations":110,"responsibleParty":128,"collaborators":39,"id":130,"slug":131,"hasResults":132,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":39,"eligibilityCriteria":136,"healthyVolunteers":132,"sex":137,"minAge":138,"maxAge":139,"enrollmentInfo":140,"targetDuration":39,"studyType":143,"phases":144,"briefSummary":146,"conditions":147,"keywords":149,"overallStatus":113,"whyStopped":39,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":164},{"fullName":5,"class":6},"General Hospital of Shenyang Military Region","OTHER",[8,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Glucocorticoids group","EXPERIMENTAL","Glucocorticoids step-down therapy combined with conventional treatment.",[13,14,15,16,17,18,19,20,21],"Drug: Methylprednisolone","Drug: Magnesium isoglycyrrhizinate","Drug: Glutathione","Drug: Silymarin","Drug: Polyene Phosphatidylcholine","Drug: Ursodeoxycholic acid capsules","Drug: Ademetionine 1,4-Butanedisulfonate","Procedure: Plaslna exchange","Procedure: Liver transplantation",{"label":23,"type":24,"description":25,"interventionNames":26},"Conventional treatment","ACTIVE_COMPARATOR","Only conventional treatment according to the Chinese practice guidelines regarding the management of DILI.",[14,15,16,17,18,19,20,21],[28,35,40,44,50,56,62,68,75],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","Methylprednisolone","Initially, an intravenous dose of 1 mg\u002Fkg\u002Fday of methylprednisolone will be administered for one week, with the possibility of extending treatment to two weeks if necessary. Following this, participants will receive oral methylprednisolone tablets, starting at a dose of 40 mg\u002Fday. The oral dosage will be gradually tapered based on the participants' condition over a period of 1 to 3 months.",[9],[34],"Medrol",{"type":29,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"Magnesium isoglycyrrhizinate","It is suitable for patients with hepatocellular or mixed DILI. A daily dose of 0.15g to 0.2g",[23,9],null,{"type":29,"name":41,"description":42,"armGroupLabels":43,"otherNames":39},"Glutathione","It is suitable for patients with hepatocellular or mixed DILI. A daily dose of 1.2g to 1.8g",[23,9],{"type":29,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"Silymarin","It is suitable for patients with hepatocellular or mixed DILI. The dosage is 140 mg, taken 2 to 3 times per day.",[23,9],[49],"Legalon",{"type":29,"name":51,"description":52,"armGroupLabels":53,"otherNames":54},"Polyene Phosphatidylcholine","It is suitable for patients with hepatocellular or mixed DILI. The dosage is 228mg-456mg, taken 3 times per day.",[23,9],[55],"Essentiale",{"type":29,"name":57,"description":58,"armGroupLabels":59,"otherNames":60},"Ursodeoxycholic acid capsules","It is suitable for patients with cholestatic or mixed DILI. A daily dose of 10mg-15mg\u002Fkg\u002Fday.",[23,9],[61],"Ursofalk",{"type":29,"name":63,"description":64,"armGroupLabels":65,"otherNames":66},"Ademetionine 1,4-Butanedisulfonate","It is suitable for patients with cholestatic or mixed DILI. A daily dose of 0.5g to 1g.",[23,9],[67],"Transmeti",{"type":69,"name":70,"description":71,"armGroupLabels":72,"otherNames":73},"PROCEDURE","Plaslna exchange","It is suitable for patients whose condition continues to worsen or even develop to liver failure.",[23,9],[74],"Artificial liver support",{"type":69,"name":76,"description":71,"armGroupLabels":77,"otherNames":39},"Liver transplantation",[23,9],[79,83,86,89,92,95,98],{"name":80,"affiliation":81,"role":82},"Xingshun Qi","Department of Gastroenterology, General Hospital of Northern Theater Command","PRINCIPAL_INVESTIGATOR",{"name":84,"affiliation":85,"role":82},"Weifen Xie","Shanghai changzheng hospital, Naval Medical University",{"name":87,"affiliation":88,"role":82},"Xin Zeng","Shanghai East Hospital,Tongji University School of Medicine",{"name":90,"affiliation":91,"role":82},"Lu Zhou","General Hospital, Tianjin Medical University",{"name":93,"affiliation":94,"role":82},"Fengmei Wang","Tianjin First Central Hospital",{"name":96,"affiliation":97,"role":82},"Qing Ye","Tianjin Third Central Hospital",{"name":99,"affiliation":100,"role":82},"Yanjing Gao","Qilu Hospital of Shandong University",[102,106],{"name":80,"role":103,"phone":104,"phoneExt":39,"email":105},"CONTACT","18909881019","xingshunqi@126.com",{"name":107,"role":103,"phone":108,"phoneExt":39,"email":109},"Qianqian Li","13940307473","1208594776@qq.com",[111],{"facility":112,"status":113,"city":114,"state":115,"zip":116,"country":117,"countryCode":118,"cosmosGeoPoint":119,"geoPoint":124,"contacts":125},"Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)","RECRUITING","Shenyang","Liaoning","110840","China","CN",{"type":120,"coordinates":121},"Point",[122,123],123.43278,41.79222,{"lat":123,"lon":122},[126,127],{"name":80,"role":103,"phone":104,"phoneExt":39,"email":105},{"name":107,"role":103,"phone":108,"phoneExt":39,"email":109},{"type":82,"investigatorFullName":80,"investigatorTitle":129,"investigatorAffiliation":5,"oldNameTitle":39,"oldOrganization":39},"Director of Department of Gastroenterology","100586998","glucocorticoids-for-acute-drug-induced-liver-injury-with-hyperbilirubinemia-100586998",false,"NCT06922669","Glucocorticoids for Acute Drug Induced Liver Injury With Hyperbilirubinemia","Efficacy and Safety of Glucocorticoids for Acute Drug Induced Liver Injury With Hyperbilirubinemia: A Multicenter Randomized Controlled Trial","Inclusion Criteria:\n\n* A definite diagnosis of acute DILI;\n* 5×ULN ≤ TBIL level at baseline ≤ 20×ULN;\n* Age 18-80 years old;\n* Sign the informed consent form.\n\nExclusion Criteria:\n\n* Other causes of liver injury, including viral hepatitis, cytomegalovirus infection, Epstein-Barr virus infection, Herpes virus infection, autoimmune liver disease, alcoholic liver disease, hypoxic\u002Fischemic liver disease, Budd-Chiari syndrome, biliary tract disease, Wilson's disease, hemochromatosis, and α1-antitrypsin deficiency;\n* Immune checkpoint inhibitors or gynura segetum induced DILI;\n* Absolute contraindications to glucocorticoids, such as systemic mold infections or allergies;\n* A history of glucocorticoid therapy within 3 months before enrollment;\n* A history of diseases requiring glucocorticoid maintenance therapy, such as rheumatoid arthritis, systemic lupus erythematosus, systemic dermatomyositis, etc;\n* A history of liver transplantation;\n* Received artificial liver therapy before enrollment;\n* Malignant tumor of the liver, bile duct, pancreas or liver metastasis\n* Acute liver failure;\n* Renal dysfunction, creatinine Cr≥133μmol\u002FL;\n* Neutrophil count \\\u003C1,000,000,000\u002FL;\n* Active tuberculosis;\n* Severe cardiopulmonary diseases;\n* Recent surgery or trauma;\n* Mental illness;\n* Pregnancy or lactation;\n* Participated in other clinical studies within 3 months before enrollment;\n* Other conditions judged by the clinician to be inappropriate for study participation.","ALL","18 Years","80 Years",{"count":141,"type":142},232,"ESTIMATED","INTERVENTIONAL",[145],"NA","Drug-induced liver injury (DILI) can lead to potentially fatal complications, such as acute liver failure and even death. In clinical practice, glucocorticoids have been considered in some cases of DILI, especially patients with hyperbilirubinemia. However, the available evidence remains controversial and its quality is also very limited. Herein, a multicenter randomized controlled trial (RCT) has been designed to explore the efficacy and safety of glucocorticoids in patients with acute DILI and hyperbilirubinemia.",[148],"Drug Induced Liver Injury",[150,151,152,153,154],"Drug induced liver injury","liver failure","glucocorticoids","clinical trial","Hyperbilirubinemia","2025-12-17",{"date":157,"type":158},"2025-12-18","ACTUAL",{"date":160,"type":158},"2025-06-24",{"date":162,"type":142},"2027-09-30",{"name":5,"class":6},1]