Predicting liver injury in autoimmune hepatitis using a specific antibody test
Prospective Multicenter Study: PredIcting SterOid DepeNdEnt LivEr Injury (PIONEER) with Polyreactive Immunoglobulin G
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 |
|---|---|
| Enrollment | 200 (estimated) |
| Sex | All |
| Sponsor | Hannover Medical School Academic / other |
| Locations | 8 sites (Aachen and 7 other locations) |
| Trial ID | NCT05810480 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals undergoing diagnostic liver biopsies for suspected liver diseases.
Not a fit: Patients with ongoing immunosuppression or those undergoing biopsies for already known liver diseases may not benefit from this study.
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 performed: Other studies have shown promise in using specific antibody tests for diagnosing autoimmune conditions, suggesting potential success for this novel approach.
Eligibility criteria
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: * 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), …)
Where this trial is running
Aachen and 7 other locations
- University Medical Centre Aachen — Aachen, Germany (Recruiting)
- University Hospital Bonn — Bonn, Germany (Recruiting)
- University Medical Center Hamburg-Eppendorf — Hamburg, Germany (Recruiting)
- Hannover Medical School — Hanover, Germany (Recruiting)
- University Medical Center Heidelberg — Heidelberg, Germany (Recruiting)
- University Hospital Schleswig-Holstein, Location Lübeck — Lübeck, Germany (Recruiting)
- University Hospital Magdeburg — Magdeburg, Germany (Recruiting)
- Rostock University Medical Centre — Rostock, Germany (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.