Clinical Trials Logo
  1. Home
  2. Autoimmune Liver Disease
  3. NCT05810480

PredIcting sterOid depeNdEnt livEr injuRy With Polyreactive Immunoglobulin G — PIONEER  

Autoimmune Hepatitis Clinical Trial

Official title:
Prospective Multicenter Study: PredIcting sterOid depeNdEnt livEr Injury (PIONEER) With Polyreactive Immunoglobulin G

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05810480
Study type Observational
Source Hannover Medical School
Contact Bastian Engel, Dr.
Phone +49 511 532 6766
Email Engel.Bastian@mh-hannover.de
Status Recruiting
Phase
Start date June 6, 2023
Completion date January 2025
View Details
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06020976 - Pattern of Autoimmune Hepatitis in Children In Sohag University Hospital
Recruiting NCT05476900 - A Study to Evaluate the Efficacy and Safety of HR19042 Capsules in the Treatment of Autoimmune Hepatitis. Phase 2
Recruiting NCT05635266 - Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
Recruiting NCT06250309 - Mediterranean Diet Versus Western Diet on Fatigue in Autoimmune Hepatitis Patients N/A
Recruiting NCT01661842 - Umbilical Cord Mesenchymal Stem Cells for Patients With Autoimmune Hepatitis Phase 1/Phase 2
Terminated NCT04339621 - AIH Risk Stratification With Multiparametric MRI
Not yet recruiting NCT04371718 - Effect of JKB-122 on Prednisolone and Azathioprine Induced Remission in Autoimmune Hepatitis (AIH) Phase 2
Completed NCT02239562 - sPIF CLINICAL STUDY PROTOCOL IN AUTOIMMUNE HEPATITIS Phase 1
Recruiting NCT05569759 - A Study of Zetomipzomib (KZR-616) in Patients With Autoimmune Hepatitis (PORTOLA) Phase 2
Completed NCT02463331 - Association of Chloroquine and Prednisone as an Alternative Treatment for Autoimmune Hepatitis Phase 4
Not yet recruiting NCT06356506 - A Study on Factors of Biochemical Response in Autoimmune Hepatitis
Terminated NCT04203875 - Abatacept for Treatment of Recurrent or de Novo Autoimmune Hepatitis Phase 1
Recruiting NCT06078098 - Development of a Autoimmune Hepatitis Patient's Database Linked to a Biological Sample Storage
Completed NCT00838214 - Budesonide 3x3mg/d Versus Prednisone in Active Autoimmune Hepatitis Phase 2/Phase 3
Recruiting NCT03743272 - Repeatability and Reproducibility of Multiparametric MRI
Completed NCT03979053 - Quantitative Magnetic Resonance Imaging to Aid Clinical Decision Making in Autoimmune Hepatitis.
Not yet recruiting NCT04902807 - Conception of a Diagnosis, Prognosis and Therapeutic Decision Tool for Patients With Autoimmunity and Inflammation
Recruiting NCT04933292 - A Randomised Clinical Trial Assessing the Efficacy and Safety of Mycophenolate Mofetil Versus Azathioprine for Induction of Remission in Treatment Primary Biliary Cholangitis-Autoimmune Hepatitis Overlap Syndrome Phase 4
Not yet recruiting NCT06455280 - SIPLIZUMAB in AILD and LT Phase 1
Completed NCT05532345 - Discrimination of DILI and AIH by Artificial Intelligence