NCT05810480 PredIcting SterOid DepeNdEnt LivEr InjuRy with Polyreactive Immunoglobulin G
| NCT ID | NCT05810480 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hannover Medical School |
| Condition | Autoimmune Hepatitis |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-06-06 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2023-06-06 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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: * No 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), …)
Contact & Investigator
Bastian Engel, Dr.
PRINCIPAL INVESTIGATOR
Hannover Medical School
Frequently Asked Questions
Who can join the NCT05810480 clinical trial?
This trial is open to participants of all sexes, studying Autoimmune Hepatitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05810480 currently recruiting?
Yes, NCT05810480 is actively recruiting participants. Contact the research team at Engel.Bastian@mh-hannover.de for enrollment information.
Where is the NCT05810480 trial being conducted?
This trial is being conducted at Aachen, Germany, Bonn, Germany, Hamburg, Germany, Hanover, Germany and 4 additional locations.
Who is sponsoring the NCT05810480 clinical trial?
NCT05810480 is sponsored by Hannover Medical School. The principal investigator is Bastian Engel, Dr. at Hannover Medical School. The trial plans to enroll 200 participants.