Predicting liver injury in autoimmune hepatitis using a specific antibody test
Official title: Prospective Multicenter Study: PredIcting sterOid depeNdEnt livEr Injury (PIONEER) With Polyreactive Immunoglobulin G
Run by Hannover Medical School · NCT05810480 · Data updated 2026-11-12
This study is testing if a specific antibody test can help doctors better diagnose autoimmune hepatitis in both adults and children, especially when other tests don't show clear results.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | Hannover Medical School Academic / other |
| Locations | 6 sites (Aachen and 5 other locations) |
| Status | Recruiting |
| Started | June 6, 2023 |
| Main results expected | July 2028 |
| Study ends | January 2029 |
| Registry record updated | July 15, 2026 |
| Trial ID | NCT05810480 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are individuals undergoing diagnostic liver biopsies for suspected liver diseases.
✕Probably not a fit
Patients with ongoing immunosuppression or those undergoing biopsies for already known liver diseases may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to evaluate the diagnostic capacity of polyreactive immunoglobulin G (pIgG) in predicting autoimmune hepatitis (AIH) compared to other liver diseases. The study will utilize a homemade ELISA to quantify pIgG levels in patients undergoing diagnostic liver biopsies. By assessing the presence of pIgG, the researchers hope to improve diagnostic accuracy for AIH, particularly in cases where conventional autoantibodies are negative. The study will include adults and children diagnosed with various liver diseases to establish the effectiveness of pIgG as a diagnostic tool.
Why it matters
Potential benefit: If successful, this study could lead to more accurate diagnoses of autoimmune hepatitis, allowing for timely and appropriate treatment.
How similar studies have gone: Other studies have shown promise in using specific antibody tests for diagnosing autoimmune conditions, suggesting potential success for this novel approach.
Who can join: the full rules
Show full inclusion / exclusion 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: * 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
Where it's running
-
Hannover Medical School
Hanover, Germany Recruiting -
RWTH Aachen
Aachen, Germany Not yet recruiting -
University Medical Center Hamburg-Eppendorf
Hamburg, Germany Not yet 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
Study contacts
- Principal investigator: Bastian Engel, Dr. — Hannover Medical School
- Study coordinator: Bastian Engel, Dr.
- Email: Engel.Bastian@mh-hannover.de
- Phone: +49 511 532 6766
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.