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PredIcting sterOid depeNdEnt livEr injuRy With Polyreactive Immunoglobulin G

Study acronym: PIONEER
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Notable Enrollment target: 200 to 400v5 Show 6 more changesShow less
    • Primary completion date: Jul 2026 to Jul 2028
    • Primary endpoints: 1 to 2
    • Study sites: 8 to 6
    • Study completion date: Jan 2027 to Jan 2029
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: 2 to 3
  2. Notable Primary completion date: Jul 2024 to Jul 2026
    • Study completion date: Jan 2025 to Jan 2027
    • Site contacts updated at 1 of 8 sites
    v4
  3. Minor Study sites: 1 to 8v3
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jun 2023 to Jun 6, 2023
    v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05810480
Lead Sponsor Hannover Medical School
Conditions
(from sponsor)
Autoimmune Hepatitis, Autoimmune Liver Disease
Related terms Hepatitis, Autoimmune
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov