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Austrian PBC Registry (PBC-AUT)

16. maj 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

500

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Østrig
    • Carinthia
      • Klagenfurt, Carinthia, Østrig, 9020
        • Ikke rekrutterer endnu
        • Klinikum Klagenfurt Am Wörthersee
        • Ledende efterforsker:
          • Markus Peck-Radosavljevic
        • Kontakt:
          • Markus Peck-Radosavljevic
          • Telefonnummer: +43 463 538 31103
          • E-mail: markus@peck.at
    • Lower Austria
      • Sankt Pölten, Lower Austria, Østrig, 3100
        • Ikke rekrutterer endnu
        • Universitätsklinikum St. Pölten
        • Ledende efterforsker:
          • Andreas Maieron
        • Kontakt:
    • State of Salzburg
      • Salzburg, State of Salzburg, Østrig, 5020
        • Ikke rekrutterer endnu
        • Universitätsklinikum Salzburg
        • Ledende efterforsker:
          • Elmar Aigner
        • Kontakt:
    • State of Vienna
      • Vienna, State of Vienna, Østrig, 1090
      • Vienna, State of Vienna, Østrig, 1030
      • Vienna, State of Vienna, Østrig, 1160
    • Styria
      • Graz, Styria, Østrig, 8036
        • Ikke rekrutterer endnu
        • Medizinische Universität Graz
        • Ledende efterforsker:
          • Peter Fickert
        • Kontakt:
    • Tyrol
      • Innsbruck, Tyrol, Østrig, 6020
        • Ikke rekrutterer endnu
        • Medizinische Universität Innsbruck
        • Kontakt:
        • Ledende efterforsker:
          • Herbert Tilg
    • Upper Austria
      • Linz, Upper Austria, Østrig, 4010
        • Ikke rekrutterer endnu
        • Ordensklinikum Linz - Barmherzige Schwestern
        • Kontakt:
        • Ledende efterforsker:
          • Stephanie Hametner-Schreil
      • Linz, Upper Austria, Østrig, 4020
        • Ikke rekrutterer endnu
        • Kepler Universitätsklinikum
        • Ledende efterforsker:
          • Alexander Moschen
        • Kontakt:
      • Wels, Upper Austria, Østrig, 4600
        • Ikke rekrutterer endnu
        • Klinikum Wels-Grieskirchen
        • Kontakt:
        • Ledende efterforsker:
          • Harald Hofer

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Transplant-free survival
Tidsramme: Through study completion, an average of 5 years
Time from inclusion to death or liver transplantation
Through study completion, an average of 5 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Medical University of Vienna

Samarbejdspartnere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

18. marts 2026

Primær færdiggørelse (Anslået)

1. december 2040

Studieafslutning (Anslået)

1. december 2040

Datoer for studieregistrering

Først indsendt

5. maj 2026

Først indsendt, der opfyldte QC-kriterier

16. maj 2026

Først opslået (Faktiske)

20. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2309/2025

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

IPD-planbeskrivelse

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).

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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