Prospective Multicenter Study: PredIcting SterOid DepeNdEnt LivEr Injury (PIONEER) with Polyreactive Immunoglobulin G

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• Diagnostic liver biopsy for the work-up of any liver disease

• Informed consent

• Definition of any liver disease according to current societal guidelines

Locations
Other Locations
Germany
University Medical Centre Aachen
RECRUITING
Aachen
University Hospital Bonn
RECRUITING
Bonn
University Medical Center Hamburg-Eppendorf
RECRUITING
Hamburg
Hannover Medical School
RECRUITING
Hanover
University Medical Center Heidelberg
RECRUITING
Heidelberg
University Hospital Schleswig-Holstein, Location Lübeck
RECRUITING
Lübeck
University Hospital Magdeburg
RECRUITING
Magdeburg
Rostock University Medical Centre
RECRUITING
Rostock
Contact Information
Primary
Bastian Engel, Dr.
Engel.Bastian@mh-hannover.de
+49 511 532 6766
Backup
Richard Taubert, Dr.
Taubert.Richard@mh-hannover.de
+49 511 532 6766
Time Frame
Start Date: 2023-06-06
Estimated Completion Date: 2027-01
Participants
Target number of participants: 200
Treatments
Autoimmune Hepatitis
This group includes patients with a diagnosis of Autoimmune Hepatitis according to the simplified diagnostic criteria by Hennes et al. made by the local treating physician. The diagnosis of autoimmune hepatitis additionally requires steroid dependency \> six months for this study to discriminate Autoimmune Hepatitis from autoimmune like drug-induced liver injury (DILI) which are hard to discriminate at diagnosis and with the latter often being treating with a short course of corticosteroids less than six months. One serum sample will be stored for anonymized evaluation of serum autoantibodies
non-autoimmune hepatitis liver disease
This group includes patients with a diagnosis of any non-viral liver disease that is not autoimmune hepatitis and whose diagnosis necessitated a diagnostic liver biopsy in the work-up of the liver disease for local care. One serum sample will be stored for anonymized evaluation of serum autoantibodies
Related Therapeutic Areas
Sponsors
Leads: Hannover Medical School

This content was sourced from clinicaltrials.gov