Condition: Autoimmune Hepatitis · Autoimmune Liver Disease · Sponsor: Hannover Medical School
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 inf…
This description comes directly from the study's public registry record.
Bastian Engel, Dr. · +49 511 532 6766 · Engel.Bastian@mh-hannover.de
Richard Taubert, Dr. · +49 511 532 6766 · Taubert.Richard@mh-hannover.de
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| RWTH Aachen | Aachen, Germany | Not Yet Recruiting |
| University Medical Center Hamburg-Eppendorf | Hamburg, Germany | Not Yet Recruiting |
| Hannover Medical School | Hanover, Germany | Recruiting |
| University Medical Center Heidelberg | Heidelberg, Germany | Not Yet Recruiting |
| University Hospital Schleswig-Holstein, Location Lübeck | Lübeck, Germany | Not Yet Recruiting |
| Rostock University Medical Centre | Rostock, Germany | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT05810480