Prospective Multicenter Study: PredIcting sterOid depeNdEnt livEr Injury (PIONEER) With Polyreactive Immunoglobulin G
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 13
- 主要终点
- Prediction of steroid dependent hepatitis
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnostic liver biopsy for the work-up of any liver disease
- •Informed consent
- •Definition of any liver disease according to current societal guidelines
排除标准
- •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
结局指标
主要结局
Prediction of steroid dependent hepatitis
时间窗: Assessment of steroid dependency at six months after enrollment
Prediction of steroid dependent hepatitis by elevated polyreactive immunoglobulin G
Sensitivity of new simplified pIgG AIH Score
时间窗: Assessment of steroid dependency at six months after enrollment
Autoimmune serology will be substituted by pIgG in the 2021 simplified AIH Score. Sensitivity of the new score will be compared to the old score, primarily for non-inferiority and second for superiority if non-inferiority was met.
Specificty of pIgG simplified AIH Score
时间窗: Assessment at baseline
Autoimmune serology will be substituted by pIgG in the 2021 simplified AIH Score. Sensitivity of the new score will be compared to the old score, primarily for non-inferiority and second for superiority if non-inferiority was met.
次要结局
- Diagnostic discrimination between AIH and DILI by polyreactive IgG(At enrollment)
- Prediction of steroid dependent hepatitis by any other autoantibody(Assessment of steroid dependency at six months after enrollment)
- Age-dependency of autoantibodies(Assessment of autoantibodies at baseline)
研究者
Engel, Bastian Dr.
Principal Investigator
Hannover Medical School