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PredIcting sterOid depeNdEnt livEr injuRy With Polyreactive Immunoglobulin G

Recruitingn/aAges any - anyAllHannover Medical School
NCT05810480 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * Diagnostic liver biopsy for the work-up of any liver disease * Informed consent * Definition of any liver disease according to current societal guidelines Exclusion Criteria: * Ongoing immunosuppression at the liver biopsy or prior to the liver biopsy * Liver biopsies for the grading or staging of an already known liver disease (e.g. non-alcoholic fatty liver disease (NAFLD), Hepatitis B/D Virus Infections (HBV/HDV Infection), …) * known liver disease * missing informed consent * patients or caregivers who can not provide informed consent
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What it tests

  • polyreactive immunoglobulin G
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Where

6 sites
RWTH Aachen
Aachen, Germany
University Medical Center Hamburg-Eppendorf
Hamburg, Germany
Hannover Medical School
Hanover, Germany
University Medical Center Heidelberg
Heidelberg, Germany
University Hospital Schleswig-Holstein, Location Lübeck
Lübeck, Germany
Rostock University Medical Centre
Rostock, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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