此页面是自动翻译的，不保证翻译的准确性。请参阅英文版对于源文本。

Austrian PBC Registry (PBC-AUT)

2026年5月16日更新者：Prof. Michael Trauner, MD、Medical University of Vienna

Characterisation of Patients With Primary Biliary Cholangitis in Austria - A Prospective Registry and Biobank

The goal of this registry is to better understand how primary biliary cholangitis develops over time, including the role of disease-related biomarkers, complications of the disease, and symptom burden. Patients with primary biliary cholangitis treated at participating centres in Austria will be invited to take part in this prospective registry. Participation in an associated biobank is optional. Clinical and laboratory data will be collected, and patients will be followed regularly through scheduled clinic visits. In addition, biological samples (serum, plasma, and, if available, liver tissue) may be collected and stored in the biobank for future research.

研究概览

地位

招聘中

条件

详细说明

This is a prospective, multicenter registry of patients with primary biliary cholangitis (PBC). Patients presenting to hepatology outpatient clinics at participating centers in Austria will be offered inclusion in the registry. For patients who are already under care at the respective center at the time of enrollment, retrospective data will be collected and subsequently complemented with prospective follow-up data. Registry participants will be managed according to current treatment guidelines and standard clinical practice at the discretion of the individual investigators. Demographic, clinical, and laboratory parameters will be recorded at the time of registry inclusion and subsequently at follow-up visits. The frequency of clinical visits will be determined by clinical necessity and will generally occur every 3-6 months, although shorter intervals may be required. No study-specific interventions will be performed. If diagnostic material is obtained as part of routine clinical care (e.g., blood sampling or liver biopsy), patients will be asked to provide informed consent for the storage of additional material (blood) or residual material (liver biopsy specimens) in a biobank for research purposes. Next to the detailed characterization of patients by epidemiologic, clinical and laboratory parameters, the presence of overlapping liver disease etiologies and the severity of liver disease will be assessed. Specifically, this includes the assessment of liver-related complications including events of hepatic decompensation, measurements of liver and spleen stiffness, as well as an assessment of portal hypertension severity based on imaging findings and hepatic venous pressure gradient measurement in selected patients. Furthermore, assessments include a detailed evaluation of current and prior disease-specific treatments and extrahepatic symptom burden. Data will be entered into a pseudonymized database by study personnel. Data transfer from participating centers to the Medical University of Vienna will be conducted either via encrypted electronic transfer or by direct transfer using encrypted hardware (e.g., hard drives or USB devices). Patient identifiers (e.g., name) will not be entered into the database. All other patient data will be recorded as datasets in a pseudonymized data table. All participating patients will be assigned a consecutive study number, thereby ensuring pseudonymization for subsequent analyses. This pseudonymization through assignment of a unique study number will also apply to samples stored in the associated biobank. Access to the data will be restricted to authorized personnel. A stated objective of the registry is the systematic inclusion of patients with PBC-associated liver disease who are managed at the specialized outpatient clinic of Vienna General Hospital or at specialized outpatient clinics of participating centers. This is particularly relevant from an epidemiological perspective to determine and capture the number of patients across different clinical stages of the disease. Therefore, the aim is to include all patients with PBC who are willing to participate from these specialized outpatient clinics, and no formal sample size calculation has been performed. Participants included in this registry are unlikely to derive any direct benefit from participation. As participation in the registry and the associated biobank does not involve any invasive procedures, no relevant risks are expected. Patients may withdraw their participation in the registry and/or the biobank at any time.

研究类型

观察性的

注册 (估计的)

500

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

姓名：Michael Trauner, MD
电话号码：+43 1 40400 47410
邮箱：Michael.Trauner@meduniwien.ac.at

研究联系人备份

姓名：Benedikt S Hofer, MD
电话号码：+43 1 40400 47410
邮箱：Benedikt.S.Hofer@meduniwien.ac.at

学习地点

奥地利
- Carinthia
  - Klagenfurt、Carinthia、奥地利、9020
    - 尚未招聘
    - Klinikum Klagenfurt Am Worthersee
    - 首席研究员：
      
      Markus Peck-Radosavljevic
    - 接触：
      
      Markus Peck-Radosavljevic
      
      电话号码：+43 463 538 31103
      
      邮箱：markus@peck.at
- Lower Austria
  - Sankt Pölten、Lower Austria、奥地利、3100
    - 尚未招聘
    - Universitätsklinikum St. Pölten
    - 首席研究员：
      
      Andreas Maieron
    - 接触：
      
      Andreas Maieron
      
      电话号码：+43 2742 9004 12311
      
      邮箱：Andreas.Maieron@stpoelten.lknoe.at
- State of Salzburg
  - Salzburg、State of Salzburg、奥地利、5020
    - 尚未招聘
    - Universitätsklinikum Salzburg
    - 首席研究员：
      
      Elmar Aigner
    - 接触：
      
      Elmar Aigner
      
      电话号码：+43 (0)5 7255 25401
      
      邮箱：E.Aigner@salk.at
- State of Vienna
  - Vienna、State of Vienna、奥地利、1090
    - 招聘中
    - Medizinische Universität Wien
    - 首席研究员：
      
      Michael Trauner
    - 接触：
      
      Michael Trauner
      
      电话号码：+43 1 40400 47410
      
      邮箱：Michael.Trauner@meduniwien.ac.at
    - 接触：
      
      Benedikt S Hofer
      
      邮箱：Benedikt.S.Hofer@meduniwien.ac.at
    - 副研究员：
      
      Benedikt S Hofer
  - Vienna、State of Vienna、奥地利、1030
    - 尚未招聘
    - Klinik Landstrasse
    - 接触：
      
      Nikolaus Pfisterer
      
      电话号码：+43 1 71165 0
      
      邮箱：Nikolaus.Pfisterer@gesundheitsverbund.at
    - 首席研究员：
      
      Nikolaus Pfisterer
  - Vienna、State of Vienna、奥地利、1160
    - 尚未招聘
    - Klinik Ottakring
    - 接触：
      
      Michael Gschwantler
      
      电话号码：+43 1 491 50 0
      
      邮箱：michael.gschwantler@gesundheitsverbund.at
    - 首席研究员：
      
      Michael Gschwantler
- Styria
  - Graz、Styria、奥地利、8036
    - 尚未招聘
    - Medizinische Universität Graz
    - 首席研究员：
      
      Peter Fickert
    - 接触：
      
      Peter Fickert
      
      电话号码：+43 316 38580686
      
      邮箱：Peter.Fickert@medunigraz.at
- Tyrol
  - Innsbruck、Tyrol、奥地利、6020
    - 尚未招聘
    - Medizinische Universität Innsbruck
    - 接触：
      
      Herbert Tilg
      
      电话号码：+43 50 504 23539
      
      邮箱：Herbert.Tilg@i-med.ac.at
    - 首席研究员：
      
      Herbert Tilg
- Upper Austria
  - Linz、Upper Austria、奥地利、4010
    - 尚未招聘
    - Ordensklinikum Linz - Barmherzige Schwestern
    - 接触：
      
      Stephanie Hametner-Schreil
      
      电话号码：+43 732 7677 7610
      
      邮箱：Stephanie.Hametner-Schreil@ordensklinikum.at
    - 首席研究员：
      
      Stephanie Hametner-Schreil
  - Linz、Upper Austria、奥地利、4020
    - 尚未招聘
    - Kepler Universitätsklinikum
    - 首席研究员：
      
      Alexander Moschen
    - 接触：
      
      Alexander Moschen
      
      电话号码：+43 5 7680 83 6120
      
      邮箱：Alexander.Moschen@kepleruniklinikum.at
  - Wels、Upper Austria、奥地利、4600
    - 尚未招聘
    - Klinikum Wels-Grieskirchen
    - 接触：
      
      Harald Hofer
      
      电话号码：+43 7242 415 2181
      
      邮箱：Harald.Hofer@klinikum-wegr.at
    - 首席研究员：
      
      Harald Hofer

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

成人
年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Patient with primary biliary cholangitis diagnosed and/or treated at one of the participating centers in Austria will be screened for inclusion/exclusion criteria.

描述

Inclusion Criteria:

Age >18 years
Confirmed diagnosis of primary biliary cholangitis (at least two of the following three criteria must be fulfilled: persistent elevation of alkaline phosphatase above the upper limit of normal for at least 6 months; presence of antimitochondrial antibodies or PBC-specific antinuclear antibodies; characteristic histopathology)
Written informed consent for participation in the registry

Exclusion Criteria:

Withdrawal of written informed consent

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Transplant-free survival 大体时间：Through study completion, an average of 5 years	Time from inclusion to death or liver transplantation	Through study completion, an average of 5 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Medical University of Vienna

合作者

Medical University of Graz

Klinikum Wels-Grieskirchen

Klinik Ottakring

Medical University Innsbruck

Klinikum Klagenfurt am Wörthersee

Kepler University Hospital

Krankenanstalt Rudolfstiftung

Salzburger Universitätsklinkum

Ordensklinikum Linz GmbH Krankenhaus Barmherzige Schwestern

Universitätsklinikum St. Pölten

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年3月18日

初级完成 (估计的)

2040年12月1日

研究完成 (估计的)

2040年12月1日

研究注册日期

首次提交

2026年5月5日

首先提交符合 QC 标准的

2026年5月16日

首次发布 (实际的)

2026年5月20日

研究记录更新

最后更新发布 (实际的)

2026年5月20日

上次提交的符合 QC 标准的更新