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Prospective Multicenter Study: PredIcting SterOid DepeNdEnt LivEr Injury (PIONEER) with Polyreactive Immunoglobulin G
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.
Age
All ages
Sex
ALL
Healthy Volunteers
No
University Medical Centre Aachen
Aachen, Germany
University Hospital Bonn
Bonn, 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
University Hospital Magdeburg
Magdeburg, Germany
Rostock University Medical Centre
Rostock, Germany
Start Date
June 6, 2023
Primary Completion Date
July 1, 2026
Completion Date
January 1, 2027
Last Updated
October 16, 2024
200
ESTIMATED participants
polyreactive immunoglobulin G
DIAGNOSTIC_TEST
Lead Sponsor
Hannover Medical School
NCT04902807
NCT05750498
Data Source & Attribution
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