PredIcting SterOid DepeNdEnt LivEr InjuRy with Polyreactive Immunoglobulin G
NCT ID: NCT05810480
Last Updated: 2024-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2023-06-06
2027-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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
polyreactive immunoglobulin G
Polyreactive immunoglobulin G will be tested centralized in Hannover as published (Taubert, Engel et al., Hepatology, 2022). The current standard diagnostic autoantibodies (e.g. ANA, anti-SMA, anti-LKM, anti-LC1, anti-SLA/L) will be tested centrally in Hannover according to current guidelines.
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
polyreactive immunoglobulin G
Polyreactive immunoglobulin G will be tested centralized in Hannover as published (Taubert, Engel et al., Hepatology, 2022). The current standard diagnostic autoantibodies (e.g. ANA, anti-SMA, anti-LKM, anti-LC1, anti-SLA/L) will be tested centrally in Hannover according to current guidelines.
Interventions
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polyreactive immunoglobulin G
Polyreactive immunoglobulin G will be tested centralized in Hannover as published (Taubert, Engel et al., Hepatology, 2022). The current standard diagnostic autoantibodies (e.g. ANA, anti-SMA, anti-LKM, anti-LC1, anti-SLA/L) will be tested centrally in Hannover according to current guidelines.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Informed consent
* Definition of any liver disease according to current societal guidelines
Exclusion Criteria
* 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), …)
ALL
No
Sponsors
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Hannover Medical School
OTHER
Responsible Party
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Engel, Bastian Dr.
Principal Investigator
Principal Investigators
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Bastian Engel, Dr.
Role: PRINCIPAL_INVESTIGATOR
Hannover Medical School
Richard Taubert, Dr.
Role: PRINCIPAL_INVESTIGATOR
Hannover Medical School
Locations
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University Medical Centre Aachen
Aachen, , Germany
University Hospital Bonn
Bonn, , Germany
University Medical Center Hamburg-Eppendorf
Hamburg, , Germany
Hannover Medical School
Hanover, , Germany
University Medical Center Heidelberg
Heidelberg, , Germany
University Hospital Schleswig-Holstein, Location Lübeck
Lübeck, , Germany
University Hospital Magdeburg
Magdeburg, , Germany
Rostock University Medical Centre
Rostock, , Germany
Countries
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Central Contacts
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Facility Contacts
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Tony Bruns, MD, Prof.
Role: primary
Karsten Grosse, MD
Role: backup
Leona Dold, MD
Role: primary
Marcial Sebode, MD
Role: primary
Norman Junge, MD
Role: backup
Uta Merle, MD, Prof.
Role: primary
Jessica Seessle, MD
Role: backup
Henrike Dobbermann, MD
Role: primary
Verena Keitel-Anselmino, MD, Prof.
Role: primary
Theresia Blattmann, MD
Role: primary
References
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Taubert R, Engel B, Diestelhorst J, Hupa-Breier KL, Behrendt P, Baerlecken NT, Suhs KW, Janik MK, Zachou K, Sebode M, Schramm C, Londono MC, Habes S; UK-AIH Consortium; Oo YH, Lalanne C, Pape S, Schubert M, Hust M, Dubel S, Thevis M, Jonigk D, Beimdiek J, Buettner FFR, Drenth JPH, Muratori L, Adams DH, Dyson JK, Renand A, Graupera I, Lohse AW, Dalekos GN, Milkiewicz P, Stangel M, Maasoumy B, Witte T, Wedemeyer H, Manns MP, Jaeckel E. Quantification of polyreactive immunoglobulin G facilitates the diagnosis of autoimmune hepatitis. Hepatology. 2022 Jan;75(1):13-27. doi: 10.1002/hep.32134. Epub 2021 Dec 5.
Other Identifiers
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PIONEER
Identifier Type: -
Identifier Source: org_study_id
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