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Идёт набор NCT05810480

PredIcting sterOid depeNdEnt livEr injuRy With Polyreactive Immunoglobulin G

— Наблюдательное Autoimmune Hepatitis Autoimmune Liver Disease

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: polyreactive immunoglobulin G.
Кому может быть актуально
Состояния в реестре: Autoimmune Hepatitis, Autoimmune Liver Disease. Базовые параметры: Без ограничений · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Германия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

  • Диагностический тест 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.

Первичные конечные точки

  • Sensitivity of new simplified pIgG AIH Score [Срок оценки: Assessment of steroid dependency at six months after enrollment]
  • Specificty of pIgG simplified AIH Score [Срок оценки: Assessment at baseline]
Вторичные конечные точки (3)
  • Diagnostic discrimination between AIH and DILI by polyreactive IgG [Срок оценки: At enrollment]
  • Prediction of steroid dependent hepatitis by any other autoantibody [Срок оценки: Assessment of steroid dependency at six months after enrollment]
  • Age-dependency of autoantibodies [Срок оценки: Assessment of autoantibodies at baseline]

Критерии участия

Критерии включения

  • Diagnostic liver biopsy for the work-up of any liver disease
  • Informed consent
  • Definition of any liver disease according to current societal guidelines

Критерии исключения

  • 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), …)
  • known liver disease
  • missing informed consent
  • patients or caregivers who can not provide informed consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Германия · 6 центров
  • RWTH Aachen — Aachen
  • University Medical Center Hamburg-Eppendorf — Hamburg
  • Hannover Medical School — Hanover
  • University Medical Center Heidelberg — Heidelberg
  • University Hospital Schleswig-Holstein, Location Lübeck — Lübeck
  • Rostock University Medical Centre — Rostock

Публикации

  • 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 PMID 34473365

Идентификаторы

NCT: NCT05810480 · PIONEER

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗