[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100577339":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":30,"locations":39,"responsibleParty":55,"collaborators":26,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":26,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":26,"studyType":70,"phases":71,"briefSummary":74,"conditions":75,"keywords":26,"overallStatus":78,"whyStopped":26,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Institute of Liver and Biliary Sciences, India","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"PLEX with SMT","EXPERIMENTAL","High Volume Plex with minimum 3 sessions on alternate days along with Standard treatment.",[13,14],"Biological: High volume Plasma Exchange","Other: Standard Medical Treatment",{"label":16,"type":17,"description":18,"interventionNames":19},"Standard Medical Treatment","ACTIVE_COMPARATOR","Standard treatment.",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BIOLOGICAL","High volume Plasma Exchange","High volume Plasma Exchange with minimum 3 sessions on alternate days",[9],null,{"type":6,"name":16,"description":28,"armGroupLabels":29,"otherNames":26},"Standard Medical Treatment includes stopping the offending drug,nutrition,injection NAC,Tablet UDCA,steroid in DILI AIH",[9,16],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":26,"email":35},"Dr Khushboo Yadav, MD","CONTACT","01146300000","ky29277@gmail.com",{"name":37,"role":33,"phone":34,"phoneExt":26,"email":38},"Dr Shasthry SM, DM","shasthry@gmail.com",[40],{"facility":41,"status":26,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Institute of Liver & Biliary Sciences (ILBS)","New Delhi","National Capital Territory of Delhi","110070","India","IN",{"type":48,"coordinates":49},"Point",[50,51],77.2148,28.62137,{"lat":51,"lon":50},[54],{"name":32,"role":33,"phone":34,"phoneExt":26,"email":35},{"type":56,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100577339","phase-2-efficacy-of-plasmapheresis-in-patients-of-drug-induced-liver-injury-dili-with-underlying-chronic-liver-disease-100577339",false,"NCT06797011","Efficacy of Plasmapheresis in Patients of Drug-Induced Liver Injury (DILI) With Underlying Chronic Liver Disease","Efficacy of Plasmapheresis in Patients of Drug-Induced Liver Injury (DILI) With Underlying Chronic Liver Disease: An Open Labelled RCT","Inclusion Criteria:\n\n1. Adults aged 18-75 years with previously known or unknown underlying CLD.\n2. Diagnosis of DILI based causality of assessment by RECAM.\n3. Severe DILI with bilirubin \\> 12mg\u002Fdl or INR\\>2, S.Bili \\>5 mg\u002Fdl.\n4. Consent to participate in the study (based on biopsy\u002Fimaging\u002For clinical criteria).\n\nExclusion Criteria:\n\n1. Active infection\n2. Contraindications to plasmapheresis (e.g., severe coagulopathy, hemodynamic instability, patients with sepsis, shock, poor P\u002FF ratio).\n3. Pregnant or breastfeeding women.\n4. HCC or any malignancy\n5. UGI bleed, uncontrolled HE\n6. Option LTx being considered\n7. S. Creatinine \\> 2mg\u002FdL\n8. DILI ALF\n9. Alcoholic Hepatitis","ALL","18 Years","75 Years",{"count":68,"type":69},96,"ESTIMATED","INTERVENTIONAL",[72,73],"PHASE2","PHASE3","DILI is an underdiagnosed and under appreciated causal or contributing factor to liver injury. DILI can mimics features of the entire spectrum of acute and chronic liver disease.\n\nAsia-Pacifc region is characterized by two unique features; the high prevalence of tuberculosis (TB) in the population and the ubiquitous use of traditional and complimentary medicines.Current definition of Hy's law presents significant difficulties when dealing with patients with preexisting CLD in clinical trials. Hallmark of the hepatic manifestation in these patients is hyperbilirubinemia and coagulopathy rather than ALT elevation.",[76,77],"Drug Induced Liver Injury","Chronic Liver Disease","NOT_YET_RECRUITING","2025-01-27",{"date":81,"type":82},"2025-01-28","ACTUAL",{"date":84,"type":69},"2025-01-25",{"date":86,"type":69},"2026-01-31",{"name":5,"class":6},1]