[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"autoimmune-hepatitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:autoimmune-hepatitis":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,20,0,[8,47,71,101,125,148,178,206,247,269,303,324,344,365,382,407,427,451,478,500],{"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":4,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100642297","molecular-characterization-of-autoimmune-hepatitis-a-lipidomic-approach-100642297",false,"NCT07644936","Molecular Characterization of Autoimmune Hepatitis: A Lipidomic Approach","Molecular Characterization of Autoimmune Hepatitis Through Lipidomic Analysis and Extracellular Vesicle Profiling: A Controlled Pilot Clinical Study","AIH-LIPID","Inclusion Criteria:\n\nARM A:\n\n* Confirmed diagnosis of autoimmune hepatitis (AIH);\n* Adult age (≥18 years);\n* Ability to provide written informed consent; Attending the Hepatology Outpatient Unit of IRCCS \"S. de Bellis\"\n\nARM B:\n\nExclusion Criteria:\n\n* Confirmed diagnosis of non-alcoholic fatty liver disease (NAFLD);\n* Adult age (≥18 years);\n* Ability to provide written informed consent; Attending the Hepatology Outpatient Unit of IRCCS \"S. de Bellis\"\n\nEsclusion Criteria:\n\n* Liver cirrhosis;\n* Active oncological diseases;\n* Viral hepatitis (HBV, HCV, HIV infection);\n* Severe medical conditions that may compromise study participation","ALL","18 Years",{"count":20,"type":21},24,"ESTIMATED","OBSERVATIONAL","This is a two-arm, prospective, controlled observational pilot clinical study aimed at characterizing the lipidomic profile and extracellular vesicles (EVs) of patients with autoimmune hepatitis (AIH) compared to patients with non-alcoholic fatty liver disease (NAFLD). A total of 24 adult outpatients will be enrolled at the Hepatology Outpatient Unit of IRCCS \"S. de Bellis\". Blood samples will be collected by venipuncture to perform lipidomic analyses on red blood cell membranes and serum, and to isolate and characterize EVs. No intervention beyond standard clinical practice will be applied",[25,26],"Autoimmune Hepatitis","Non-Alcoholic Fatty Liver Disease",[28,29,30,31,32,33],"autoimmune hepatitis","lipidomic analysis","extracellular vesicles","fatty acids","biomarkers","NAFLD","NOT_YET_RECRUITING","2026-06-15",{"date":37,"type":38},"2026-06-16","ACTUAL",{"date":40,"type":21},"2026-07-01",{"date":42,"type":21},"2028-07-01",{"name":44,"class":45},"Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":18,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":46},"100602065","host-diet-gut-interaction-post-vegan-diet-in-pediatric-autoimmune-hepatitis-100602065","NCT07118657","Host-Diet-Gut Interaction Post Vegan Diet in Pediatric Autoimmune Hepatitis.","Inclusion Criteria:\n\n1. Cases diagnosed as Autoimmune hepatitis (AIH).\n2. Controls are healthy subjects.\n\nExclusion Criteria:\n\n1. Recent (\\\u003C 6 weeks) exposure to oral or intravenous antibiotics, probiotics\u002Fprebiotics, proton pump inhibitors, or herbal medicines.\n2. Any history of malignancy or any gastrointestinal tract surgery.\n3. Recent (\\\u003C 2 weeks) gastrointestinal infection.\n4. Any dietary allergies .","0 Years",{"count":55,"type":21},40,"INTERVENTIONAL",[58],"NA","Pediatric autoimmune liver diseases (AILDs), including autoimmune hepatitis (AIH) and overlap syndromes like sclerosing cholangitis, are among the most common chronic liver conditions in the pediatric population. Currently, the treatment for AIH often involves long-term use of immunosuppressive therapy, which carries risks of severe side effects both in the short and long term. Due to these potential adverse effects, there is a critical need to explore alternative therapies that can modulate autoimmunity and potentially reduce or eliminate the dependence on immunosuppressive drugs. Autoimmune diseases, including AIH, typically arise in genetically predisposed individuals after exposure to certain environmental factors, leading to a breakdown in self-tolerance.The gut microbiome plays a crucial role in modulating the immune system through both anti-inflammatory and pro-inflammatory pathways. In advanced liver diseases, factors such as intestinal dysmotility, small intestinal bacterial overgrowth (SIBO), and increased intestinal permeability contribute to enhanced bacterial translocation, consistent with the \"leaky gut\" hypothesis. This phenomenon allows the passage of toxins, antigens, and bacteria into the systemic circulation, potentially exacerbating autoimmune responses. Consequently, altering the gut microbiome through dietary changes, probiotics, prebiotics, or fecal microbiota transplantation presents a promising therapeutic approach for autoimmune diseases.This study aims to investigate the gut microbiome and its modification following dietary intervention (specifically, a plant-based vegan diet) in pediatric AIH. Additionally, investigator will explore the potential role of such interventions in managing intestinal dysfunction in patients with advanced liver disease. In Aim 1, investigator will compare the baseline gut microbiome profiles of treatment-naïve pediatric AIH patients with those of healthy, age- and sex-matched controls to provide foundational insights. In Aim 2, investigator will evaluate the proportion of patients achieving biochemical remission after 180 days of a vegan versus standard diet in AIH patients. Investigator will also assess changes in stool metagenomics, metabolomics, cytokine profiles, gut epithelial barrier function, and liver disease severity scores between the two dietary groups.\n\nThis study aims to demonstrate the potential benefits of a vegan diet in managing autoimmune hepatitis. It seeks to provide evidence supporting dietary modifications as a complementary approach to standard medical treatments for a wide range of autoimmune or autoimmune-like disorders, potentially paving the way for future therapeutic strategies.",[25],"RECRUITING","2026-06-10",{"date":64,"type":38},"2026-06-12",{"date":66,"type":38},"2026-02-11",{"date":68,"type":21},"2028-04-30",{"name":70,"class":45},"Institute of Liver and Biliary Sciences, India",{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":56,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":4},"100638086","phase-3-a-trial-of-inebilizumab-in-participants-with-autoimmune-hepatitis-100638086","NCT07598825","A Trial of Inebilizumab in Participants With Autoimmune Hepatitis","A Phase 2\u002F3, Randomized, Double-blind, Multicenter, Placebo-controlled Study of Inebilizumab in Participants With Autoimmune Hepatitis","MERCURY","Inclusion Criteria:\n\n* Signed informed consent.\n* Age ≥ 18 years or legal adult age within the country, whichever is older and \\\u003C 75 years at the time of signing the informed consent.\n* Participants must have either inadequate response to at least 9 months of SOC or are intolerant to SOC within 6 months of screening. Inadequate response to SOC treatment is defined as ALT ≥ 2 upper limit of normal (ULN) at screening after at least 9 months of SOC, including prednisone (or equivalent) \\> 5 mg\u002Fday and at least one conventional steroid sparing agent at guideline-concordant target or highest appropriate dose, that is azathioprine (AZA) or 6-mercaptopurine (6-MP) at appropriate weight-based dosing (typically up to 2 mg\u002Fkg\u002Fday AZA or 1 mg\u002Fkg\u002Fday 6-MP) or mycophenolate (MMF) up to 2 g\u002Fday, as judged appropriate by the investigator and documented in the medical record.\n\nIntolerance to SOC treatment is defined as any clinically significant adverse event related to treatment that results in discontinuation of the medication or prevents dose optimization necessary to achieve or maintain biochemical response, as determined by the Principal Investigator (PI). Intolerance applies to GCs, AZA, 6-MP, or MMF. Presence of one or more clinically significant adverse effects attributed to SOC include but not limited to side effects that, in the opinion of the investigator, compromise participant's safety or quality of life, exacerbate comorbid conditions, or render continued use medically inappropriate.\n\n* Participants with disease activity at screening as follows: ALT ≥ 2 x ULN to ≤ 7 x ULN. ALT ULN values will be gender specific.\n* Participant must have a biopsy proven definitive diagnosis of AIH according to simplified diagnostic criteria (score ≥ 7). Liver biopsy should be obtained within 90 days prior to randomization. Participants must have a mHAI score ≥ 5 in the biopsy.\n* Participant should be on:\n\n  * No increase in GC dose during the 28 days immediately preceding whichever biopsy is designated as the baseline sample-historical or screening-and the dose post biopsy must remain unchanged through the day of randomization AND\n  * Stable maximum tolerated doses of AZA or 6-MP for at least 12 weeks prior to screening (baseline) liver biopsy until randomization and during the entire treatment period unless dose reduction is deemed necessary for safety or tolerance reasons OR\n  * Stable maximum tolerated doses of MMF\u002Fmycophenolic acid (MPA) for at least 12 weeks prior to screening (baseline) liver biopsy until randomization and during the entire treatment period unless dose reduction is deemed necessary for safety or tolerance reasons.\n* Participants must use protocol-specified contraception during treatment and for an additional 6 months after the last dose of trial intervention.\n\nExclusion Criteria:\n\n* Diagnosis of definitive overlap autoimmune liver or rheumatologic syndrome with autoimmune hepatitis (eg, AIH + primary biliary cholangitis \\[PBC\\], AIH + primary sclerosing cholangitis \\[PSC\\], AIH related to Systemic Lupus Erythematosus, etc) where established overlap criteria are met.\n* Acute liver failure (ALF) at screening (e.g., acute hepatic dysfunction with coagulopathy and any degree of encephalopathy) in the investigator's judgment.\n* Participant has known history of:\n\n  * Allergy or reaction to any component of inebilizumab formulation or history of anaphylaxis to any human gamma globulin therapy.\n  * Allergy to or intolerance of protocol-required treatment, including medications for prophylaxis of infusion reactions (antipyretic such as paracetamol\u002Facetaminophen or equivalent, diphenhydramine or equivalent, and methylprednisolone or equivalent).\n* Active malignancy or history of malignancy that was active within the last 10 years, except as follows:\n\n  * In situ carcinoma of the cervix treated with apparent success with curative therapy for \\> 12 months prior to screening\n  * Curatively treated breast ductal carcinoma in situ\n  * Cutaneous basal cell or squamous cell carcinoma treated with apparent success with curative therapy for \\> 12 months prior to screening\n  * Prostate cancer treated with radical prostatectomy or radiation therapy with curative intent \\> 3 years prior to screening and without known recurrence or current treatment\n  * Thyroid cancer for which complete surgical resection has been performed within 5 years with well-differentiated histology (papillary thyroid carcinoma or follicular thyroid carcinoma) and there is no evidence of active disease.\n* Known positive test for human immunodeficiency virus (HIV) infection. Evidence of HIV infection or positive for HIV antibodies at initial screening or current acquired, common variable or inherited, primary or secondary immunodeficiency.\n* Presence or history of viral hepatitis infection:\n\n  * Positive test for, or prior treatment for, hepatitis B. A positive test for hepatitis B is detection of either:\n\n    * Positive for hepatitis B surface antigen (HBsAg) OR\n    * anti-HBc\n  * Participants with a history of or current hepatitis C virus (HCV) infection, even those considered to be cured.\n* Active tuberculosis (TB) or latent TB with no documented history of adequate treatment per local SOC.\n* Positive test for TB during screening is defined as positive QuantiFERON® test. At screening, all participants must be tested with an interferon-γ release assay (IGRA) (QuantiFERON®).\n* History of \\> 1 episode of herpes zoster (any grade) and\u002For any other definite or probable opportunistic infection in the 12 months prior to screening.\n* Estimated glomerular filtration rate \\\u003C 45 mL\u002Fmin\u002F1.73 m\\^2 using chronic kidney disease epidemiology (CKD-EPI) 2021 formula.\n* Blood tests at screening that meet any of the following criteria:\n\n  * Hemoglobin \\\u003C 7.5 g\u002FdL\n  * Neutrophils \\\u003C 1200\u002Fmm\\^3\n  * Platelets \\\u003C 150 x 10\\^9\u002FL\n  * international normalized ratio (INR) \\> 1.3\n  * cluster of differentiation 19 (CD19)+ B cells at screen \\\u003C 40 cells\u002FµL; an exclusionary value may be repeated.\n  * Serum albumin level \\\u003C 35 g\u002FL\n  * Direct bilirubin (BIL) in serum \\>ULN\n  * Total BIL ≥ 2.0 mg\u002FdL\n  * ALP \\> 1.5 x ULN\n  * AST \\> 7 x ULN Note: Participants with baseline cytopenia (where permitted) may be enrolled if, in the Investigator's judgment, the cytopenia derives from an alternative to AIH condition (eg, medication effect, nutritional deficiency, anemia of chronic disease etc).\n* Active, clinically significant infection at the time of randomization (investigational product administration may be delayed until recovery, if within screening window, otherwise participant may be rescreened).\n* History or evidence of uncontrolled alcohol use disorder (AUD), defined as participants who have a history of significant alcohol consumption, ie, consumption of \\>2 units\u002Fday for males and \\>1 unit\u002Fday for females, sustained for ≥ 3 consecutive months.\n* History of recurrent significant infections (eg, requiring hospitalization or IV antibiotics) within the past 12 months.\n* Major surgery within 8 weeks before screening.\n* Severe cardiovascular, respiratory, endocrine, gastrointestinal, hematological, neurological, psychiatric, or systemic disorder, or any other condition that, in the opinion of the Investigator, would place the participant at unacceptable risk of complications, interfere with evaluation of the Investigational product or confound the interpretation of participant safety or trial results.\n* Known immunodeficiency disorder.\n* Participants with moderate-to-severe metabolic dysfunction-associated steatohepatitis (MASH) on screening\u002Fbaseline liver biopsy, defined by central pathology review as steatosis grade ≥ 2 with lobular inflammation ≥ 1, and hepatocellular ballooning ≥ 1.\n* Participants with decompensated cirrhosis, either historical or present at screening defined by:\n\n  * Histologic cirrhosis on screening or prior liver biopsy (fibrosis stage F4 \u002F Ishak 5-6), and\n  * Prior hepatic decompensation or Child-Pugh B-C.\n  * Child-Pugh category A at screening, without a history of prior hepatic decompensation (ascites, encephalopathy, variceal bleeding, spontaneous bacterial peritonitis \\[SBP\\], hepatorenal syndrome \\[HRS\\], acute-on-chronic liver failure, or progression to decompensated cirrhosis), is eligible.\n* Participant with a history of drug-induced liver injury (DILI), regardless of offending agent.\n* Receipt of any biologic B cell-depleting therapy (eg, rituximab, ocrelizumab, obinutuzumab, ofatumumab, inebilizumab, ianalumab) in the 6 months prior to screening.\n* Receipt of non-depleting B cell-directed therapy (eg, belimumab), abatacept, or other biologic immunomodulatory agent within 6 months prior screening.\n* Receipt of tumor necrosis factor (TNF) inhibitors (eg, infliximab, adalimumab) within 6 months prior screening.\n* Receipt of immunosuppressive agents such as calcineurin inhibitors (tacrolimus, cyclosporin except eye drops), methotrexate, mammalian target of rapamycin inhibitors (eg, everolimus) within 6 weeks prior screening.\n* Receipt of any investigational agent \\\u003C 12 weeks or \\\u003C 5 half-lives of the drug (whichever is longer) prior to screening.\n* History of inability to be tapered off of GC therapy due to adrenal insufficiency or due to recurrent or prolonged systemic glucocorticoid therapy for any medical condition other than AIH (eg, severe steroid-dependent asthma) according to PI.\n* All vaccines are prohibited within 4 weeks before the first dose of trial treatment.\n\n  * Participants are recommended to be administered vaccines at least 4 weeks prior to dosing in accordance with local recommendations prior to enrollment to allow for adequate immune response.\n* Required regular use of medications with known hepatotoxicity.\n* Current use of:\n\n  * GCs (prednisone \\> 20 mg\u002Fday, or equivalent dose of other GCs)\n  * AZA \\> 2 mg\u002Fkg\u002Fday\n  * 6-MP \\> 1 mg\u002Fkg\u002Fday\n  * MMF \\> 2 g\u002Fday or MPA \\> 1440 mg\u002Fday.\n* Any concomitant immunosuppressive treatment, alone or in combination with GCs, except for AZA, 6-MP, MMF, and MPA.\n* Undetectable levels of 6-thioguanine nucleotides (6-TGN) or MPA during screening unless participants are not on AZA or MMF\u002FMPA due to intolerance per protocol.\n* No new Herbal and Dietary Supplements (HDS) products for 4 weeks prior to first dose of inebilizumab.\n* Currently receiving a trial intervention, or less than 30 days or 5 half-lives if known (whichever is later) since ending a trial intervention in another investigational device or drug trial.\n* Unable to safely undergo a liver biopsy.\n* Participant unlikely to be able to complete all protocol-required procedures, restrictions and requirements, in the judgment of the individual and investigator.\n* History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator, would pose a risk to participant safety.\n* Currently pregnant (confirmed with positive pregnancy test) or breastfeeding or planning to become pregnant, donate eggs, or breastfeed while on trial until an additional 6 months after the last dose of inebilizumab (if applicable) with highest teratogenic risk.\n* Participants of childbearing potential with a positive pregnancy test assessed by serum pregnancy test at screening and a urine pregnancy test at Day 1 visit.\n* Participant unwilling to abstain from donating blood or plasma during the trial.\n\nIn order for participants to continue to OLP, they must:\n\n* Have completed the randomized controlled treatment period Week 78 visit and received all doses or not discontinued investigational product for any of the following reasons:\n\n  * Anaphylaxis or a serious hypersensitivity reaction that occurred within 7 days after IV dosing and cannot be attributed to another known allergen exposure.\n  * Any adverse events or significant laboratory abnormality that, in the opinion of the investigator, Amgen, or Data Monitoring Committee (DMC), warrants discontinuation of dosing.\n  * Any life-threatening (grade 4) infection.\n  * Any event of sepsis or febrile neutropenia.\n  * Any infection listed as either a definite or probable opportunistic infection.\n  * Any grade 3 infusion related reactions (IRR).\n  * Any grade 4 serious adverse events.\n  * Pregnancy or a decision to become pregnant.\n  * Malignancy.\n  * Absolute neutrophil count \\\u003C 800 cells\u002FµL confirmed by repeat testing.\n  * Determination that the participant was ineligible for trial participation and continuation of investigational product could pose a safety risk to the participant in the judgment of the investigator or the sponsor.\n  * Significant noncompliance with the trial protocol, as judged by the investigator or Amgen.\n* Receive dose 1 in the OLP within the window of 7 days after the randomized controlled treatment period Week 78 visit and only after the Week 78 biopsy has been completed.\n* Participants who meet protocol-defined early escape criteria and discontinue the RCP may enter the OLP, provided they have not discontinued investigational product for safety-related reasons that preclude further dosing.","74 Years",{"count":81,"type":21},180,[83],"PHASE3","The main objectives of this trial are to evaluate the safety and tolerability of inebilizumab in participants with autoimmune hepatitis (AIH) (Part 1) and to evaluate the efficacy of inebilizumab on AIH disease activity and glucocorticoid (GC) use in the management of AIH (Part 2).",[25,86],"AIH",[88,86,89,90],"Autoimmune hepatitis","Inebilizumab","AMG 335","2026-05-14",{"date":93,"type":38},"2026-05-20",{"date":95,"type":21},"2026-09-07",{"date":97,"type":21},"2034-02-11",{"name":99,"class":100},"Amgen","INDUSTRY",{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":108,"enrollmentInfo":109,"targetDuration":4,"studyType":56,"phases":111,"briefSummary":112,"conditions":113,"keywords":114,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":46},"100535321","mediterranean-diet-versus-western-diet-on-fatigue-in-autoimmune-hepatitis-patients-100535321","NCT06250309","Mediterranean Diet Versus Western Diet on Fatigue in Autoimmune Hepatitis Patients","Randomized Crossover Diet Study Comparing Impact of Mediterranean Diet to Western Diet on Fatigue in Autoimmune Hepatitis Patients","Inclusion Criteria:\n\n* Established autoimmune hepatitis (AIH) confirmed according to simplified criteria (\\>6) or historical confirmatory liver biopsy with inflammation consistent with AIH\n* Therapeutically stable AIH: no changes to immunosuppression (corticosteroids or baseline immunosuppression) within 4 weeks of study enrollment\n* Previous enrollment in the Indiana University GRACE study\n* Fatigue domain score (PROMIS-29) more than population mean (PROMIS 29 score): T-score ≥ 55\n* Diagnosis of AIH \\> 6 months\n* Current age: 18 to 80 years old\n* Willing and agree to comply with protocol requirements\n* Female patients who are of reproductive potential must agree for the duration of the study to use an effective means of contraception (e.g., abstinence, hormonal contraception methods that inhibit ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal ligation, vasectomized partner)\n* Capable of storing 1 week duration of frozen food and preparing meals\n* Capable of receiving weekly frozen food on scheduled day of delivery\n* Capable of understanding and signing the informed consent document\n\nExclusion Criteria:\n\n* Concurrent diagnosis of celiac disease\n* Concurrent use of dedicated dietary intervention (patient driven or else)\n* Established diagnosis of variant syndrome (AIH with Primary biliary cholangitis, AIH with Primary sclerosing cholangitis)\n* Child Pugh score \\> 7\n* MELDNa score \\> 7\n* Clinical evidence of de-compensated cirrhosis: ascites, total bilirubin \\>1.5, large esophageal varices or history of bleeding, known diagnosis of hepatic encephalopathy\n* Women who are pregnant or breastfeeding or intend to become so for the entire duration of the study; this information will be self-reported; no pregnancy test will be performed\n* History of liver transplantation\n* Current treatment with an investigational drug\n* Historical intolerance or allergy to foods included in a Mediterranean Diet or a Western Diet","80 Years",{"count":110,"type":21},48,[58],"This is a single-center, proof-of-concept pilot study which uses a cross-over design to compare two dietary interventions\u002Ftreatments: Western Diet (WD) vs Mediterranean (MD) and impact on quality-of-life parameters in AIH. Participants will receive both treatments through two phases and will be divided into two groups.",[25],[115],"fatigue","2026-05-05",{"date":118,"type":38},"2026-05-08",{"date":120,"type":38},"2023-10-23",{"date":122,"type":21},"2028-12-31",{"name":124,"class":45},"Indiana University",{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":108,"enrollmentInfo":133,"targetDuration":4,"studyType":56,"phases":134,"briefSummary":136,"conditions":137,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":147},"100545403","phase-2-belimumab-in-autoimmune-hepatitis-100545403","NCT06381453","Belimumab in Autoimmune Hepatitis","Belimumab in the Management of Autoimmune Hepatitis: A Multi-centre, Open-label Trial of add-on Belimumab Therapy to Standard of Care","BELief","Inclusion Criteria:\n\n* Ability to provide written informed consent\n* Established clinical diagnosis of autoimmune hepatitis for at least 6 months\n* Participant and clinician consent to follow AIH study therapy guidance for the duration of the open label clinical trial.\n\nGroup A:\n\n* ALT \\> 1.5 x ULN in the absence of clinical evidence or concern for alternative etiology, and assessed by the investigator as related to active AIH using standard of care evaluation.\n* Ongoing therapy with corticosteroids, and\u002For non-biologic immunosuppressants (AZA, MMF, MP) at a stable dosage for 4 weeks prior to screening\n\nGroup B:\n\n* Patients with normal ALT and normal IgG concentration\n* Ongoing therapy with single agent immunosuppression or immunosuppression with low dose Prednisone (10mg or less or budesonide 6mg or less)) alongside a second line agent (azathioprine, MMF, MP)\n* Fibroscan showing liver stiffness of \\\u003C 16kPa.\n\nExclusion Criteria:\n\n* Primary liver disease other than AIH\n* High probability of NAFLD as assessed by the investigator.\n* ALT \\>15 x ULN\n* Patients positive for HBsAg or HBcAb and\u002For Hepatitis C RNA\n* Prior use if corticosteroid \\>15mg daily\n* A positive pregnancy test and\u002For breast feeding\n* The presence of advanced liver disease as defined by any of:\n\n  1. Total Bilirubin \\>3 x ULN.\n  2. Platelet count \\\u003C100 x109\u002FL.\n  3. INR \\>1.5\n* Live vaccines within 30 days prior to screening or at any time during the study\n* The use of other biologics including TNF inhibitors, abatacept, or tocilizumab within the washout period",{"count":110,"type":21},[135],"PHASE2","Background: Autoimmune hepatitis (AIH) is a rare chronic and lifelong liver disease. Untreated, disease progresses to end-stage cirrhosis and the focus of therapy is with immunosuppression. Current therapies are limited, not targeted, and associated with side effects that patients report reduce quality of life. AIH is believed to arise as a consequence of genetic \\& environmental risks. Disease is characterised by impaired immunoregulation, that favours a chronic and relapsing hepatitis. As well as recognising an important role for cytotoxic T cells and regulatory T cells, it has become apparent that in AIH, as well as other related autoimmune conditions, that B-cells are important. AIH is characterised by a plasma cell rich interface hepatitis and elevated IgG concentrations. Furthermore B-cell lineages interact with regulatory T-cells. Off-label use of Rituximab, an anti-CD20 agent, has been described for patients with AIH. A number of other ways of effectively targeting B-cells in the treatment of related autoimmune diseases have also been developed, but there have been limited studies in people living with autoimmune hepatitis. Belimumab is a human monoclonal antibody that inhibits B-cell activating factor (BAFF), also known as B-lymphocyte stimulator. It is approved in the Canada to treat systemic lupus erythematosus and lupus nephritis. It has not been studied before in AIH, but off-label reports are published. In an open-label clinical trial of people living with autoimmune hepatitis, the investigator will now formally study the effect of adding Belimumab to existing standard of care, with the goal being to evaluate treatment efficacy, the ability to reduce the burden of existing therapies whilst still controlling AIH disease, and to describe the tolerability \\& safety of Belimumab in people with AIH. Study Design: Open label, multi-centre, Canadian clinical trial. Patient population: Patients with autoimmune hepatitis, excluding patients with decompensated liver disease, who either have active disease despite standard of care (Group A), or who are maintained with disease remission using standard of care therapy (Group B). 48 patients will be recruited. Intervention: Weekly sub-cutaneous Belimumab. Duration: 72 weeks with interim analysis after 24 patients have been treated for 24 weeks; target recruitment 48 patients. Evaluation: Safety, Serum liver tests, quality of life, exploratory immunologic biomarkers, optional liver biopsy or fine needle liver aspirate. Primary end-point: Group A: 50% or more of subjects have an ALT\\\u003C2x ULN \\& corticosteroids at a dose of \\\u003C\u002F= 5mg of Prednisone (or equivalent); Group B: 50% or more of subjects able to maintain remission (normal ALT, normal IgG) on monotherapy with Belimumab. Conclusion: Using a combination of makers of treatment efficacy and safety the investigator will test the hypothesis that Belimumab should be further formally evaluated for people living with AIH.",[25],"2026-04-21",{"date":140,"type":38},"2026-04-24",{"date":142,"type":38},"2024-12-11",{"date":144,"type":21},"2029-04-30",{"name":146,"class":45},"University Health Network, Toronto",5,{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":154,"eligibilityCriteria":155,"healthyVolunteers":156,"sex":17,"minAge":157,"maxAge":4,"enrollmentInfo":158,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":160,"conditions":161,"keywords":165,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":46},"100555982","liver-gut-axis-study-through-identification-of-liver-disease-specific-microbiome-100555982","NCT06519162","Liver-gut Axis Study Through Identification of Liver Disease-specific Microbiome","Exploration of Liver-gut Axis Through Identification of Liver Disease-specific Microbiome","LGAS","Inclusion Criteria:\n\n* Adults aged 19 years and older diagnosed with autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, non-alcoholic fatty liver disease, or liver abscess, who have consented to participate in this study at Chungnam National University Hospital.\n* Adults aged 19 years and older, who are cohabitants of patients diagnosed with autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, non-alcoholic fatty liver disease, or liver abscess, and have consented to participate in this study at Chungnam National University Hospital.\n\nB. Exclusion\n\nExclusion Criteria:\n\n* Individuals under the age of 19.\n* Patients or guardians who do not consent to participate in the study",true,"19 Years",{"count":159,"type":21},3000,"In this study, we aim to identify gut microbiomes specific to patients with chronic refractory liver disease and to conduct a gut-liver axis study on the pathogenesis and disease progression.",[25,162,26,163,164],"Primary Sclerosing Cholangitis","Liver Abscess","Primary Biliary Cirrhosis",[166,167,168],"Liver Diseases","Microbiota","Immune System","2026-03-19",{"date":171,"type":38},"2026-03-20",{"date":173,"type":38},"2024-07-08",{"date":175,"type":21},"2029-07-08",{"name":177,"class":45},"Chungnam National University Hospital",{"id":179,"slug":180,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":184,"eligibilityCriteria":185,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":186,"targetDuration":4,"studyType":56,"phases":188,"briefSummary":190,"conditions":191,"keywords":196,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":46},"100551068","phase-1-a-study-of-siplizumab-in-aild-and-lt-patients-100551068","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",{"count":187,"type":21},8,[189],"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.",[192,193,25,162,194,195],"Autoimmune Liver Disease","Liver Transplant Disorder","End Stage Liver DIsease","Cirrhosis, Liver",[192,193,25,162,194,195],"2025-11-19",{"date":199,"type":38},"2025-11-24",{"date":201,"type":38},"2024-09-11",{"date":203,"type":21},"2028-03-31",{"name":205,"class":45},"Elizabeth C. Verna",{"id":207,"slug":208,"hasResults":11,"nctId":209,"briefTitle":210,"officialTitle":210,"acronym":211,"eligibilityCriteria":212,"healthyVolunteers":11,"sex":17,"minAge":213,"maxAge":18,"enrollmentInfo":214,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":216,"conditions":217,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":46},"100431799","conception-of-a-diagnosis-prognosis-and-therapeutic-decision-tool-for-patients-with-autoimmunity-and-inflammation-100431799","NCT04902807","Conception of a Diagnosis, Prognosis and Therapeutic Decision Tool for Patients With Autoimmunity and Inflammation","ATRACTion","Inclusion Criteria for controls (patients relatives and unrelated subjects):\n\n* Individuals aged\\\u003C18 y\u002Fo.\n* Individuals \\> 6 kg\n* Individuals not affected by an immune-related disease or not affected by cancer\n* Individuals whose parents have signed an enlightened consent.\n\nInclusion criteria for patients\n\n* Individuals with health insurance.\n* Patients treated at Necker hospital with PIDs and autoimmunity\u002Finflammation related to known genetic defects (cytopenia, Enteropathy Inflammatory bowel disease (IBD), Systemic Lupus Erythematosus (SLE), Juvenile Idiopathic Arthritis (JIA), Familial Hemophagocytic Lymphohistiocytosis (FHL), chronic EBV infection associated (Ca-EBV) with EBV-infected T and\u002For Natural Killer (NK) cells and with a high risk to develop macrophage activation syndrome similar to FHL. See table below for diagnosis inclusion criteria.\n* Individuals aged\\\u003C18 y\u002Fo.\n* Individuals \\> 9 kg\n* Patients whose parents have signed an enlightened consent.\n\nExclusion Criteria:\n\n* Intake of antibiotics within 2 weeks prior inclusion\n* Absence of parent's or child consent form\n* Cytotoxic cancer treatments\n* antiviral treatments (HIV, hepatitis …)\n* Short term life-threatening conditions\n* Individuals placed under judicial protection","1 Year",{"count":215,"type":21},500,"The main objective of this study is to generate diagnosis and therapeutic-decision tools through the identification of molecular causes of PIDs with autoimmunity\u002Finflammation and the variability in disease outcome at the transcriptional level using a combination of omics signatures (transcriptomics, epigenomics, proteomics, metagenomics, metabolomics and lipidomics).",[218,219,220,221,222,25,223,224,225,226,227,228,229,230,231,232,233,234,235,236],"Autoimmune Lymphoproliferative Syndrome","Autoimmune Cytopenia","Autoimmune Diseases","Autoimmune Anemia","Autoimmune Thrombocytopenia","Autoimmune Diabetes","Autoimmune Rheumatologic Disease","Systemic Lupus Erythematosus","Juvenile Idiopathic Arthritis","Hemophagocytic Lymphohistiocytoses","EBV Lymphoproliferation","RAS-Associated Autoimmune Leucoproliferative Disease","Primary Immunodeficiency","APECED","IPEX","BENTA","Enteropathy, Autoimmune","Combined Immunodeficiency","IBD","2025-09-02",{"date":239,"type":38},"2025-09-08",{"date":241,"type":38},"2021-09-07",{"date":243,"type":21},"2026-06",{"name":245,"class":246},"Institut National de la Santé Et de la Recherche Médicale, France","OTHER_GOV",{"id":248,"slug":249,"hasResults":11,"nctId":250,"briefTitle":251,"officialTitle":251,"acronym":4,"eligibilityCriteria":252,"healthyVolunteers":156,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":253,"targetDuration":254,"studyType":22,"phases":4,"briefSummary":255,"conditions":256,"keywords":258,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":5},"100297045","swiss-autoimmune-hepatitis-cohort-study-100297045","NCT03146884","Swiss Autoimmune Hepatitis Cohort Study","Inclusion Criteria:\n\n* diagnosis of AIH, either type I or type II\n* Only patients living in Switzerland\n\nExclusion Criteria:\n\n* N\u002FA",{"count":215,"type":21},"5 Years","Research project in which biological material is sampled and health-related personal data is further used and collected.\n\nCoded data are used.",[257,25],"Hepatitis, Autoimmune",[25,86,259],"Cohort","2025-08-14",{"date":262,"type":38},"2025-08-18",{"date":264,"type":38},"2017-02-16",{"date":266,"type":21},"2030-12-31",{"name":268,"class":45},"Fondazione Epatocentro Ticino",{"id":270,"slug":271,"hasResults":11,"nctId":272,"briefTitle":273,"officialTitle":274,"acronym":275,"eligibilityCriteria":276,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":277,"targetDuration":279,"studyType":22,"phases":4,"briefSummary":280,"conditions":281,"keywords":282,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":301,"locationsCount":187},"100496919","a-link-improving-outcomes-in-autoimmune-liver-disease-100496919","NCT05750498","A-LiNK: Improving Outcomes in Autoimmune Liver Disease","Autoimmune Liver Disease Network for Kids (A-LiNK): Using Patient Data to Transform Care and Improve Outcomes for Children, Adolescents, and Young Adults With Autoimmune Liver Disease","ALINK","Inclusion Criteria:\n\n* Clinical diagnosis of autoimmune hepatitis (AIH)\n* Clinical diagnosis of primary sclerosing cholangitis (PSC)\n* Clinical diagnosis of autoimmune sclerosing cholangitis (ASC)\n\nExclusion Criteria:\n\n• History of liver transplant",{"count":278,"type":21},800,"10 Years","The Autoimmune Liver disease Network for Kids (A-LiNK) is a multi-institutional group with the mission to deliver the best care to kids with pediatric autoimmune liver disease (AILD).\n\nThis study will establish a shared clinical registry and a learning health network for the participating sites focusing on collecting and transmitting clinical measurement data, information about processes, and participation in an improvement collaborative.\n\nPediatric Autoimmune Hepatitis (AIH) and Primary Sclerosing Cholangitis (PSC), represent a spectrum of AILD which present unique diagnostic and therapeutic challenges.A lack of accepted guidelines for disease monitoring or symptom management results in wide treatment variation with liver transplants indicated in refractory, progressive disease.\n\nThe aims of A-LiNK are to:\n\n1.) Create a learning health network focused on patient-centered outcomes research characterized by transparent sharing among centers, common priorities, and feasible plans for implementing new practices; 2) shift from traditional investigator-driven study to a patient and family-centered approach, and 3.) improve clinical outcomes and quality of life for pediatric AILD patients.",[25,162],[283,25,162,284,285,286,287,288,289,290,291,292,293],"Pediatrics","Autoimmune Sclerosing Cholangitis","Chronic Liver Disease","End-stage Liver Disease","Clinical Registry","Research Registry","Quality Improvement","Outcomes Research","Comparative Effectiveness Research","Patient Reported Outcomes","Health Services Research","2025-07-21",{"date":296,"type":38},"2025-07-24",{"date":298,"type":38},"2022-04-28",{"date":300,"type":21},"2033-06-30",{"name":302,"class":45},"Children's Hospital Medical Center, Cincinnati",{"id":304,"slug":305,"hasResults":11,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":4,"eligibilityCriteria":309,"healthyVolunteers":156,"sex":17,"minAge":310,"maxAge":18,"enrollmentInfo":311,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":313,"conditions":314,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":322,"locationsCount":4},"100584978","role-of-usp35-in-the-detection-of-ferroptosis-in-juvenile-autoimmune-hepatitis-100584978","NCT06896383","Role of USP35 in the Detection of Ferroptosis in Juvenile Autoimmune Hepatitis","Role of USP35 in the Detection of Ferroptosis in Juvenile Autoimmune Hepatitis: an Immunohistochemical Study","Inclusion Criteria:\n\n* Patients aged between one day and 18 years (children)\n* patients diagnosed clinically and physically with juvenile autoimmune hepatitis including seronegative autoimmune hepatitis cases\n\nExclusion Criteria:\n\n1. Cases with inadequate tissue in the paraffin block\n2. Children with viral hepatitis\n3. patients above the age of 18 years old","1 Day",{"count":312,"type":21},60,"1. To evaluate the immunohistochemical expression of USP35 in cases of juvenile autoimmune hepatitis and control cases.\n2. To correlate this with the level of necro-inflammation and extent of fibrosis using Massion's trichrome stain in cases of juvenile autoimmune hepatitis.",[25],"2025-03-24",{"date":317,"type":38},"2025-03-26",{"date":319,"type":21},"2025-11",{"date":321,"type":21},"2027-01",{"name":323,"class":45},"Assiut University",{"id":325,"slug":326,"hasResults":11,"nctId":327,"briefTitle":328,"officialTitle":329,"acronym":4,"eligibilityCriteria":330,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":331,"enrollmentInfo":332,"targetDuration":4,"studyType":56,"phases":334,"briefSummary":335,"conditions":336,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":337,"lastUpdatePostDateStruct":338,"startDateStruct":340,"completionDateStruct":341,"leadSponsor":343,"locationsCount":46},"100581850","efficacy-and-safety-of-therapeutic-plasma-exchange-vs-standard-medical-therapy-in-severe-autoimmune-hepatitis-100581850","NCT06855667","Efficacy and Safety of Therapeutic Plasma Exchange vs Standard Medical Therapy in Severe Autoimmune Hepatitis.","Efficacy and Safety of Therapeutic Plasma Exchange vs Standard Medical Therapy in Severe Autoimmune Hepatitis: A Pilot Randomized Controlled Study","Inclusion Criteria:\n\n1. Age 18-60 years\n2. Acute severe autoimmune hepatitis with MELD \\>24\n3. No liver transplant option \\\u003C 28 days.\n4. -ACLF + Non ACLF\n5. Auto immune hepatitis: Diagnosis by simplified AIH score ≥6\n\nExclusion Criteria:\n\n1. Patients with Active sepsis\n2. Patients with Active bleeding\n3. Patients allergic to FFP and blood products\n4. Patients with unstable hemodynamics ( eg:BP\\\u003C90\u002F60 mmhg,HR \\>100bpm)\n5. Patients with post renal obstructive AKI, AKI suspected due to glomerulonephritis, interstitial nephritis or vasculitis based on clinical history and urine analysis\n6. Pregnancy related liver failure\n7. Comorbidities associated with poor outcome (Extrahepatic neoplasia, severe cardiopulmonary disease defined by a New York Heart Association score \\>3, or oxygen\u002Fsteroid-dependent chronic obstructive pulmonary disease)\n8. Refusal to participate in the study\n9. Patients who are eligible to transplant\n10. Patients who received steroids or on steroids last 7 days","60 Years",{"count":333,"type":21},50,[58],"Autoimmune hepatitis (AIH) is a chronic inflammatory liver disease that can lead to cirrhosis and liver failure. AIH can present in all ages, races, and ethnicities, but it mostly affects women. As a heterogeneous disease, AIH presents variably in different patients, making diagnosis and treatment a challenge.It is associated with varied clinical presentations and natural history and somewhat unpredictable treatment responses. Steroids and immunosupressants are main stay of treatment.In acute severe presentations corticosteroid response rates are more variable.According to treatment guidelines if patients fail to respond to corticosteroids, Liver transplant is the only option. But Liver transplant is not feasible in all situations such as limited donor availability.Plasma exchange is associated with a reduction in levels of pro-inflammatory cytokines,DAMPs, and bacterial endotoxins and increase in the levels of anti-inflammatory cytokines.Plasma exchange has reportedly been used for acute presentations of AIH but there are few trials which prove its independent benefit and role in influencing transplant free survival.The study aims at proving the efficacy of Plasma exchange as a bridge between steroid therapy and Liver transplant.It includes the patients with acute severe autoimmune hepatitis .One group of patients are taken up for plasma exchange sessions and compared with the other group started on high dose of steroids and they will be observed for 28 days and are assessed for transplant free survival and efficacy of plasma exchange in reducing transaminitis and Bilirubin levels.",[25],"2025-03-03",{"date":339,"type":38},"2025-03-04",{"date":337,"type":21},{"date":342,"type":21},"2027-02-28",{"name":70,"class":45},{"id":345,"slug":346,"hasResults":11,"nctId":347,"briefTitle":348,"officialTitle":349,"acronym":4,"eligibilityCriteria":350,"healthyVolunteers":11,"sex":17,"minAge":351,"maxAge":352,"enrollmentInfo":353,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":355,"conditions":356,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":358,"startDateStruct":360,"completionDateStruct":362,"leadSponsor":364,"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":354,"type":21},150,"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.",[192,25,162],"2024-12-09",{"date":359,"type":38},"2024-12-12",{"date":361,"type":38},"2017-02-20",{"date":363,"type":21},"2031-02",{"name":302,"class":45},{"id":366,"slug":367,"hasResults":11,"nctId":368,"briefTitle":369,"officialTitle":370,"acronym":4,"eligibilityCriteria":371,"healthyVolunteers":11,"sex":17,"minAge":351,"maxAge":352,"enrollmentInfo":372,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":374,"conditions":375,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":376,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":381,"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":373,"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.",[192,162,25],{"date":359,"type":38},{"date":378,"type":38},"2017-01-17",{"date":380,"type":21},"2027-01-30",{"name":302,"class":45},{"id":383,"slug":384,"hasResults":11,"nctId":385,"briefTitle":386,"officialTitle":386,"acronym":4,"eligibilityCriteria":387,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":388,"enrollmentInfo":389,"targetDuration":4,"studyType":56,"phases":391,"briefSummary":392,"conditions":393,"keywords":394,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":399,"lastUpdatePostDateStruct":400,"startDateStruct":402,"completionDateStruct":404,"leadSponsor":406,"locationsCount":4},"100566049","phase-2-induction-of-remission-in-autoimmune-hepatitis-with-azathioprine-vs-mmf-100566049","NCT06650124","Induction of Remission in Autoimmune Hepatitis With Azathioprine vs. MMF","Inclusion Criteria:\n\nDiagnosis: Confirmed diagnosis of autoimmune hepatitis (AIH) based on clinical, biochemical, and histological findings.\n\nBiochemical markers: Elevated liver enzymes, specifically AST and ALT, indicating liver inflammation.\n\nTreatment-naive: Patients must be treatment-naive, meaning they have not received prior immunosuppressive therapy for AIH.\n\nWillingness to participate: Patients must provide informed consent and be willing to comply with all study-related procedures and follow-ups. -\n\nExclusion Criteria:\n\n* Acute liver failure: Patients presenting with acute liver failure at baseline will be excluded.\n\nOther liver diseases: Co-existing liver conditions such as hepatitis B, hepatitis C, primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), or any alcohol-induced liver disease will lead to exclusion.\n\nLow blood counts: Patients with a platelet count less than 50,000\u002Fmm³ or total leukocyte count (TLC) less than 3,000\u002Fmm³ will not be eligible.\n\nPrevious treatment: Patients who have already received immunosuppressive or disease-modifying therapy for AIH or related conditions.\n\nPregnancy or lactation: Pregnant or lactating women will be excluded to avoid potential risks to the mother or fetus.\n\nHepatocellular carcinoma (HCC) or malignancy: Any patients with evidence of hepatocellular carcinoma or other active malignancies.\n\nMedication allergies: Patients with known allergies to azathioprine, mycophenolate mofetil (MMF), or prednisolone will be excluded.\n\nNon-consent: Patients who are not willing to participate in the study or unable to provide informed consent.","65 Years",{"count":390,"type":21},108,[135,83],"The goal of this clinical trial is to determine the effectiveness of azathioprine (AZA) versus mycophenolate mofetil (MMF) in inducing remission in treatment-naive patients with autoimmune hepatitis (AIH). The main questions it aims to answer are:\n\nDoes MMF combined with prednisolone lead to higher remission rates compared to AZA with prednisolone after 24 weeks? Is MMF associated with fewer adverse events than AZA in these patients? Researchers will compare two treatment arms (MMF vs. AZA) to see if MMF leads to improved remission rates and safety outcomes.\n\nPrimary Outcome Measure:\n\nBiochemical remission: The primary outcome is the normalization of liver enzymes (AST, ALT) and IgG levels at 24 weeks.\n\nSecondary Outcome Measures:\n\nSafety and adverse events: Monitoring and comparing the incidence and severity of side effects between the two groups.\n\nTreatment adherence: Evaluating how well patients stick to their assigned treatment regimens.\n\nImprovement in quality of life: Assessing changes in the patient's quality of life using validated questionnaires.\n\nReversal of fibrosis: Measured by liver stiffness using Fibroscan, aiming for no progression of fibrosis.\n\nParticipants will:\n\nReceive either MMF or AZA, alongside a tapering dose of prednisolone. Be monitored regularly through clinic visits, laboratory tests, and safety assessments to track remission and any adverse events.",[25],[395,396,397,398],"utoimmune Hepatitis (AIH)","Azathioprine (AZA)","Mycophenolate Mofetil (MMF)","Induction of Remission","2024-11-05",{"date":401,"type":38},"2024-11-07",{"date":403,"type":21},"2024-11-01",{"date":405,"type":21},"2025-12-31",{"name":70,"class":45},{"id":408,"slug":409,"hasResults":11,"nctId":410,"briefTitle":411,"officialTitle":412,"acronym":413,"eligibilityCriteria":414,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":415,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":417,"conditions":418,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":419,"lastUpdatePostDateStruct":420,"startDateStruct":422,"completionDateStruct":424,"leadSponsor":425,"locationsCount":187},"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":416,"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.",[25,192],"2024-10-14",{"date":421,"type":38},"2024-10-16",{"date":423,"type":38},"2023-06-06",{"date":321,"type":21},{"name":426,"class":45},"Hannover Medical School",{"id":428,"slug":429,"hasResults":11,"nctId":430,"briefTitle":431,"officialTitle":432,"acronym":4,"eligibilityCriteria":433,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":434,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":436,"conditions":437,"keywords":438,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":442,"lastUpdatePostDateStruct":443,"startDateStruct":445,"completionDateStruct":447,"leadSponsor":449,"locationsCount":46},"100543487","a-study-on-factors-of-biochemical-response-in-autoimmune-hepatitis-100543487","NCT06356506","A Study on Factors of Biochemical Response in Autoimmune Hepatitis","A Multicenter, Prospective Cohort Study on the Influencing Factors of Biochemical Response in Autoimmune Hepatitis","Inclusion Criteria:\n\n1. ≥18 years old at the time of onset;\n2. AIH simplified score ≥6 and\u002For AIH revised score ≥10;\n3. Liver biopsy was performed and consistent with the pathological diagnosis of AIH;\n4. Patents were treatment naive or who were diagnosed and treated in other hospitals but have stopped glucocorticoid\u002Fimmunosuppressive therapy for more than 3 months;\n5. Agree to participate in this study and sign the informed consent form.\n\nExclusion Criteria:\n\n1. concomitant liver diseases: hepatotropic viral hepatitis (A, B, C, D, and E) and non-hepatotropic viral hepatitis (cytomegalovirus and Epstein-Barr virus (EBV) infection);\n2. concomitant with drug-induced liver injury, primary biliary cholangitis, primary sclerosing cholangitis, alcoholic liver disease, genetic and metabolic liver diseases;\n3. bone marrow or liver transplantation;\n4. incomplete baseline medical history and laboratory examination results;\n5. for previously diagnosed patients, immunosuppressive therapy was discontinued less than 3 months;\n6. Pregnancy or lactation;\n7. patients with contraindications to glucocorticoid\u002Fimmunosuppressive therapy;\n8. complicated with other malignant tumors;\n9. complicated with mental disorders.",{"count":435,"type":21},630,"The goal of this observational study is to clarify the clinical characteristics of autoimmune hepatitis (AIH) in China. The main questions it aims to answer are:\n\nHuman leukocyte antigen (HLA) gene susceptibility in Chinese AIH patients prognostic factors associated with AIH Participants will provide liver tests results and details of treatment during follow-up.",[25],[88,439,440,441],"Biochemical response","Prognosis","Immunosuppressive therapy","2024-04-18",{"date":444,"type":38},"2024-04-19",{"date":446,"type":21},"2024-05-01",{"date":448,"type":21},"2034-05-01",{"name":450,"class":45},"Beijing Friendship Hospital",{"id":452,"slug":453,"hasResults":11,"nctId":454,"briefTitle":455,"officialTitle":456,"acronym":457,"eligibilityCriteria":458,"healthyVolunteers":11,"sex":17,"minAge":213,"maxAge":4,"enrollmentInfo":459,"targetDuration":461,"studyType":22,"phases":4,"briefSummary":462,"conditions":463,"keywords":465,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":469,"lastUpdatePostDateStruct":470,"startDateStruct":472,"completionDateStruct":474,"leadSponsor":476,"locationsCount":46},"100522092","development-of-a-autoimmune-hepatitis-patients-database-linked-to-a-biological-sample-storage-100522092","NCT06078098","Development of a Autoimmune Hepatitis Patient's Database Linked to a Biological Sample Storage","Multicenter, Nationwide, Observational, Retrospective and Prospective Study Based on the Development of a Autoimmune Hepatitis Patient's Database Linked to a Biological Sample Storage","AIH Database","Inclusion Criteria:\n\n* All AIH patients living in Italy and aged at least 1 year can be included in the database.\n* Willing and able to give informed consent prior to any study specific procedure being\n* Diagnosis of AIH according to the most recent published guidelines (EASL)\n\nExclusion Criteria:\n\n* Subject unwilling to participate at the study",{"count":460,"type":21},10000,"11 Years","Autoimmune Hepatitis (AIH) is chronic fibroinflammatory disease of the liver characterized by chronic, relapsing liver inflammation, and a risk for progression to liver failure and need for liver transplantation. No AIH-specific registry does exist in Italy, so that the actual epidemiology of the disease in the country is unknown.\n\nThis is an observational, retrospective and prospective, multicenter study evaluating incidence, prevalence and disease course of AIH in subjects \\> 1 years old in Italy.",[25,464],"Liver Disorder",[25,466,467,468],"National Database","Liver","Epidemiology","2023-10-05",{"date":471,"type":38},"2023-10-11",{"date":473,"type":38},"2023-03-29",{"date":475,"type":21},"2034-03-29",{"name":477,"class":45},"University of Milano Bicocca",{"id":479,"slug":480,"hasResults":11,"nctId":481,"briefTitle":482,"officialTitle":483,"acronym":484,"eligibilityCriteria":485,"healthyVolunteers":11,"sex":17,"minAge":486,"maxAge":4,"enrollmentInfo":487,"targetDuration":254,"studyType":22,"phases":4,"briefSummary":489,"conditions":490,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":491,"lastUpdatePostDateStruct":492,"startDateStruct":494,"completionDateStruct":496,"leadSponsor":498,"locationsCount":46},"100499633","autoimmune-hepatitis-cohort-in-china-100499633","NCT05785793","Autoimmune Hepatitis Cohort in China","Clinical Characteristics and Outcomes of Autoimmune Hepatitis: a Retro-prospective Multicenter Cohort in China","CAMERA","Inclusion Criteria:\n\n* Age ≥ 14 years\n* Probable or definite diagnosis of autoimmune hepatitis according to the International Autoimmune Hepatitis Study Group criteria\n* Availability of all following essential parameters at the initial diagnosis of AIH: including alanine transaminase, aspartate aminotransferase, total bilirubin, alkaline phosphatase, immunoglobulin G, and platelet count\n* Provide informed consent\n\nExclusion Criteria:\n\n* Have a concomitant diagnosis of primary biliary sclerosis, primary sclerosing cholangitis, immunoglobulin G 4-related cholangitis\n* Have an active infection with hepatitis B virus, hepatitis C virus, hepatitis delta virus, HIV, cytomegalovirus, or Epstein-Barr virus\n* Have a concomitant diagnosis of hepatocellular carcinoma or other malignant diseases before the diagnosis of AIH\n* Considered ineligible to the enrollment in the clinical study by the researcher","14 Years",{"count":488,"type":21},1000,"The goal of this observational study is to describe the clinical features and long-term prognosis in patients diagnosed with autoimmune hepatitis (AIH) in China and assess the effectiveness and safety of AIH treatment options in a real-world setting.",[25],"2023-03-26",{"date":493,"type":38},"2023-03-28",{"date":495,"type":38},"2023-02-01",{"date":497,"type":21},"2028-02-01",{"name":499,"class":45},"Shanghai Jiao Tong University School of Medicine",{"id":501,"slug":502,"hasResults":11,"nctId":503,"briefTitle":504,"officialTitle":504,"acronym":505,"eligibilityCriteria":506,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":507,"targetDuration":351,"studyType":22,"phases":4,"briefSummary":509,"conditions":510,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":513,"lastUpdatePostDateStruct":514,"startDateStruct":516,"completionDateStruct":518,"leadSponsor":520,"locationsCount":521},"100329484","canadian-network-for-autoimmune-liver-disease-100329484","NCT03569826","Canadian Network for Autoimmune Liver Disease","CaNAL","Inclusion Criteria:\n\n* Diagnosis of Primary Biliary Cholangitis and\u002For Autoimmune Hepatitis\n\nExclusion Criteria:\n\n* Less than 18 years of age",{"count":508,"type":21},2500,"CaNAL is a longitudinal observational cohort study of patients diagnosed with Primary Biliary Cholangitis (PBC), Autoimmune Hepatitis (AIH), or overlap syndrome. This study creates a nationwide registry and network focusing on high quality long-term follow-up of individual patient data from major Canadian centers.\n\nPrimary Biliary Cholangitis (PBC) and Autoimmune Hepatitis (AIH) are rare and slowly progressive liver diseases associated with development of cirrhosis, liver cancer (HCC) and liver failure requiring liver transplantation or leading to premature death. The rarity and slowly progressive nature of these autoimmune liver diseases make them difficult to study and only a large scale approach combining patient data from multiple centers across Canada will allow new insights. The primary aim of the Canadian Network for Autoimmune Liver Disease is to build a Canadian registry of patients with PBC, AIH, and overlap syndrome. We capture patient characteristics, laboratory assessments and natural history, patient-reported outcomes including quality of life measures and environmental exposures, response to treatment, and pre- and post-transplant outcomes. We will then identify risk factors associated with critical outcomes for the patient, including response to treatment, progression to transplant, risk of liver cancer, and recurrent disease after transplant. We can identify biomarkers (biochemical indicators of progression of disease) to help diagnose autoimmune liver disease at its earliest stages, ensuring timely treatment and preventing disease progression. CaNAL will provide a better understanding of autoimmune liver diseases, biomarkers predictive of disease progression or non-response to therapy as well as better knowledge of the etiology and pathogenesis. CaNAL will also help to serve as a platform for conducting clinical trials or targeted lab-studies to answer important questions that are unlikely to be evaluated by the pharmaceutical industry.",[511,25,512],"Primary Bilary Cirrhosis (PBC)","Overlap Syndrome","2021-06-04",{"date":515,"type":38},"2021-06-07",{"date":517,"type":38},"2018-02-07",{"date":519,"type":21},"2028-12",{"name":146,"class":45},15]