View clinical trials related to Hepatitis, Autoimmune.
Filter by: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: Human 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.
This is a single-center, proof-of-concept pilot study which uses a cross-over design to compare two dietary interventions/treatments: 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.
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. This is an observational, retrospective and prospective, multicenter study evaluating incidence, prevalence and disease course of AIH in subjects > 1 years old in Italy.
This is an Investigator Initiated, single center, non-randomized, single arm study utilizing TruGraf liver gene expression serial testing in patients with autoimmune liver diseases (AIH, PSC, PBC) monthly for the first 6 months after transplant to help inform immunosuppression (IS) optimization. Approximately 20 patients will be enrolled in the study. Study outcomes will include 1-year graft survival, 1 year BPAR and clinically treated rejection rates, number of changes to IS based on the results of Trugraf, eGFR and immune mediated issues. TruGraf®, (Transplant Genomics, Inc., a member of Eurofins Transplant Diagnostics) is a non-invasive blood-based test to assist the clinician in lowering immunosuppression in liver transplant patients. It is the first and only blood-based test that offers biomarker guidance to aid physicians in minimizing immunosuppression in transplant recipients. Unfortunately, achieving the tight control of therapeutic levels of immunosuppression that is required to maintain the balance between "too much" and "too little" can be difficult. TruGraf liver can help clinicians confirm immune "quiescence" prior to, as well as following, immunosuppression reduction in patients with stable graft function, minimizing the risk of overt graft injury due to rejection. The clinical context of use for TruGraf is to provide reassurance to the clinician who is contemplating a preemptive reduction in IS therapy that a patient's immune status is "quiescent" thus reducing the risk of triggering acute rejection with that IS reduction. Having the ability to assess whether the patient's immune status is "quiescent" or activated when considering an increase or decrease in IS therapy allows the clinician greater confidence in decision making.
Autoimmune hepatitis (AIH) is a progressive inflammatory liver disorder of unknown etiology. If left untreated, it progresses to liver cirrhosis and liver failure. Diagnosis of AIH relies on the exclusion of other causes of liver disease and the presence of positive clinical, biochemical, and histological criteria. AIH has a very wide spectrum of clinical presentations ranging from being asymptomatic to an acute severe fulminant disease. It may be associated with other autoimmune disorders such as thyroiditis, type 1 diabetes, vitiligo, inflammatory bowel disease, or juvenile idiopathic arthritis. Biochemical features of AIH include elevation of serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), and immunoglobulin G (IgG) in addition to autoantibodies. Liver biopsy is recommended in any patient with suspected autoimmune hepatitis where interface hepatitis is the hallmark of the disease. Immunosuppression is the mainstay of therapy in AIH. Prednisone is administered as the initial therapy either alone or in combination with azathioprine. Liver transplantation is indicated in patients who develop fulminant hepatic failure that is unresponsive to corticosteroids and in patients who develop end-stage liver disease.
The investigators identified polyreactive immunoglobulin G (pIgG) in adults (published in Hepatology: https://doi.org/10.1002/hep.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/SMA positivity and equally diagnostic for AIH even when conventional autoantibodies (ANA/SMA/SLA/LKM) were negative. Additionally, the frequency of pIgG was lower than conventional autoantibodies (ANA, SMA) in vaccinia/drug associated severe liver injury in a retrospective multicenter study after Covid-19 vaccination (https://doi.org/10.1016/j.jhepr.2022.100605). Aims 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. Therefore, 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.
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.
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). This 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. Pediatric 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. The aims of A-LiNK are to: 1.) 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.
To collect, preserve, and/or distribute annotated biospecimens and associated medical data to institutionally approved, investigator-directed biomedical research to discover and develop new treatments, diagnostics, and preventative methods for specific and complex conditions.
This is a Phase 2a, multi-center, placebo-controlled study in which patients with autoimmune hepatitis will receive zetomipzomib or placebo in addition to standard-of-care for 24 weeks; an optional open-label extension period allows patients to receive zetomipzomib (KZR-616) for an additional 24 weeks of treatment.