[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"autoimmune-liver-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:autoimmune-liver-disease":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,47,70,87],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100551068","phase-1-a-study-of-siplizumab-in-aild-and-lt-patients-100551068",false,"NCT06455280","A Study of SIPLIZUMAB in AILD and LT Patients","A 12-Month, Open-Label Study Evaluating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Siplizumab as Induction Therapy in Patients With Autoimmune Liver Diseases Undergoing Liver Transplantation (SET-SAIL)","SET-SAIL","Inclusion Criteria:\n\n1. Able to provide informed consent\n2. Age ≥ 18 years old\n3. Clinical diagnosis of AIH and\u002For PSC\n4. Listed for liver transplantation\n5. Epstein-Barr virus (EBV) seropositive within 12 months of screening\n\nExclusion Criteria:\n\n1. Presence or history of significant liver disease other than AIH or PSC, including viral hepatitis, alcohol-related liver disease and biopsy-proven non-alcoholic steatohepatitis\n2. Prior transplant\n3. Listed for multiorgan transplant\n4. Acute liver failure\n5. Known malignancy, including cholangiocarcinoma and hepatocellular carcinoma\n6. Other investigational products in the last 30 days or 5 half lives\n7. Pregnant\u002Flactating or unwilling to use contraception\n8. Leukopenia (WBC less than 2,000\u002Fmm3\n9. Absolute lymphocyte count \\\u003C 200\u002Fmm3\n10. Sero-positive for HIV-1\n11. Hepatitis C Virus (HCV) antibody or RNA positive (within 6 months of screening)\n12. HBsAg, hepatitis B virus (HBV) DNA or HBcAb positive (within 6 months of screening)\n13. Alcohol use exceeding 30g\u002Fday for men or 20g\u002Fday for women, and\u002For known phosphatidylethanol (PETH) level \\>80 in the 3 months prior to LT\n14. Untreated latent TB infection as detected by QuantiFERON Gold Plus Interferon Gamma Release Assay (IGRA) (or current standard interferon gamma release assay for TB)\n15. Receipt of any live-attenuated vaccine within 2 months of transplant.\n\nADDITIONAL exclusion criteria to be reviewed at the time of transplant\n\n1. Renal failure with dialysis or with estimated glomerular filtration rate (eGFR) \\\u003C 30 at the time of LT\n2. Model for end-stage liver disease (MELD)-Na score \\>30\n3. Donor features of Donation after Cardiac Death (DCD), HCV Ab or nucleic acid testing (NAT+), HBcAb or HBsAg+, or blood types A, B, and O incompatible organ","ALL","18 Years",{"count":20,"type":21},8,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","There is a significant unmet need for safe and effective therapeutic approaches to prevent immune-mediated graft injury and its complications in liver transplant (LT) recipients with autoimmune liver disease (AILD) including autoimmune hepatitis and primary sclerosing cholangitis. Siplizumab is an anti-cluster of differentiation 2 (CD2) monoclonal antibody that has demonstrated a favorable safety profile of siplizumab in over 779 human subjects and has been shown to target memory T cells-a key driver in the immune processes surrounding rejection and autoimmunity post LT in AILD. The purpose of this pilot, open-label phase 1 study is to determine the safety of siplizumab for induction in patients with AILD undergoing LT.\n\nUp to eight (8) subjects will receive siplizumab 0.6 mg\u002Fkg\u002Fdose on the day of transplant (Day 0) and Day 4 post-transplant, for a total of two doses.\n\nAll subjects will be followed in the study for 12 months post-LT.",[27,28,29,30,31,32],"Autoimmune Liver Disease","Liver Transplant Disorder","Autoimmune Hepatitis","Primary Sclerosing Cholangitis","End Stage Liver DIsease","Cirrhosis, Liver",[27,28,29,30,31,32],"RECRUITING","2025-11-19",{"date":37,"type":38},"2025-11-24","ACTUAL",{"date":40,"type":38},"2024-09-11",{"date":42,"type":21},"2028-03-31",{"name":44,"class":45},"Elizabeth C. Verna","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":46},"100299483","mri-biomarkers-in-as-predictor-of-clinical-endpoints-in-pediatric-autoimmune-liver-disease-100299483","NCT03178630","MRI Biomarkers in as Predictor of Clinical Endpoints in Pediatric Autoimmune Liver Disease","Longitudinal Study for the Assessment of MRI Based Biomarkers as a Predictors of Clinical Endpoints in Pediatric Onset Autoimmune Liver Disease","Inclusion Criteria:\n\n1. Age 6-23 years old.\n2. Established clinical diagnosis of AIH or PSC.\n\nExclusion Criteria:\n\n1. History of liver transplantation.\n2. Chronic Hepatitis B or untreated hepatitis C virus infection.\n3. Pregnancy.\n4. Absolute contraindication for MRI (e.g. pacemaker, metallic implants, claustrophobia).\n5. Diagnosis of cystic fibrosis or biliary atresia\n6. Diagnosis of cardiac hepatopathy.\n7. Diagnosis of Wilson's disease, Alpha-1 Antitrypsin deficiency, or Glycogen storage disease.\n8. Skin conditions which could be aggravated by MREL (i.e. Epidermolysis bullosa).","6 Years","23 Years",{"count":57,"type":21},150,"OBSERVATIONAL","Autoimmune liver diseases (AILD), which include Primary Sclerosing Cholangitis (PSC) and Autoimmune Hepatitis (AIH) are a common etiological factor for chronic liver disease among adolescents. This is a longitudinal study to identify surrogate endpoints with an accurate predictive value for the progression of hepatobiliary damage in subjects with pediatric onset AILD. This study will involve collection of MRI-based data at the time of enrollment and at year 1 and 2 of follow up, and collection of clinical data for 10 years following enrollment. There is a strong possibility that MRI quantitative techniques may be more sensitive to disease progression than standard clinical and laboratory tests. To investigate predictivity of MRI based biomarkers, summary measures of MRCP\u002FMREL from baseline, Year 1 and Year 2, e.g. change rate, maximum, and average will be calculated as predictors for Year 10 clinical outcomes. The same predictors will also be used to model native liver survival in a proportional hazard regression. Findings from this study may be used to assess disease progression and to predict complications and survival of liver disease patients.",[27,29,30],"2024-12-09",{"date":63,"type":38},"2024-12-12",{"date":65,"type":38},"2017-02-20",{"date":67,"type":21},"2031-02",{"name":69,"class":45},"Children's Hospital Medical Center, Cincinnati",{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":55,"enrollmentInfo":77,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":81,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":46},"100299240","mri-based-biomarkers-in-pediatric-autoimmune-liver-disease-100299240","NCT03175471","MRI Based Biomarkers in Pediatric Autoimmune Liver Disease","Cross-sectional Study for Assessment of MRI Based Biomarkers of Bile Duct Injury and Hepatic Fibrosis in Pediatric Onset Autoimmune Liver Disease","Inclusion Criteria:\n\n1. Age 6-23 years old.\n2. Established or suspected clinical diagnosis of AIH or PSC.\n\nExclusion Criteria:\n\n1. History of liver transplantation.\n2. Chronic Hepatitis B or untreated hepatitis C virus infection.\n3. Pregnancy.\n4. Absolute contraindication for MRI (e.g. pacemaker, metallic implants, claustrophobia).\n5. Diagnosis of cystic fibrosis or biliary atresia\n6. Diagnosis of cardiac hepatopathy.\n7. Diagnosis of Wilson's disease, Alpha-1 Antitrypsin deficiency, or Glycogen storage disease.\n8. Skin conditions which could be aggravated by MREL (i.e. Epidermolysis bullosa).",{"count":78,"type":21},115,"Autoimmune liver diseases (AILD), which include Primary Sclerosing Cholangitis (PSC) and Autoimmune Hepatitis (AIH) are a common etiological factors for chronic liver disease among adolescents. In all these conditions, autoimmune lymphocyte responses are thought to orchestrate inflammatory injury against hepatocytes (primarily in AIH) or cholangiocytes (in PSC). In this proposal we aim to evaluate the Magnetic Resonance Imaging (MRI) modalities; MR cholangiopancreatography (MRCP) and MR elastography (MREL), as non-invasive biomarkers to assess two primary pathophysiological processes of AILD: bile duct damage and liver fibrosis. In this cross-sectional study MRI based findings of bile duct injury and liver fibrosis will be correlated with both liver histology and circulating biomarkers of these disease processes.",[27,30,29],{"date":63,"type":38},{"date":83,"type":38},"2017-01-17",{"date":85,"type":21},"2027-01-30",{"name":69,"class":45},{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":95,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":97,"conditions":98,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":20},"100501532","predicting-steroid-dependent-liver-injury-with-polyreactive-immunoglobulin-g-100501532","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), …)",{"count":96,"type":21},200,"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.",[29,27],"2024-10-14",{"date":101,"type":38},"2024-10-16",{"date":103,"type":38},"2023-06-06",{"date":105,"type":21},"2027-01",{"name":107,"class":45},"Hannover Medical School"]