Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Austrian PBC Registry (PBC-AUT)

16. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Detaljert 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.

Studietype

Observasjonsmessig

Registrering (Antatt)

500

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Østerrike
    • Carinthia
      • Klagenfurt, Carinthia, Østerrike, 9020
        • Har ikke rekruttert ennå
        • Klinikum Klagenfurt Am Worthersee
        • Hovedetterforsker:
          • Markus Peck-Radosavljevic
        • Ta kontakt med:
          • Markus Peck-Radosavljevic
          • Telefonnummer: +43 463 538 31103
          • E-post: markus@peck.at
    • Lower Austria
      • Sankt Pölten, Lower Austria, Østerrike, 3100
        • Har ikke rekruttert ennå
        • Universitätsklinikum St. Pölten
        • Hovedetterforsker:
          • Andreas Maieron
        • Ta kontakt med:
    • State of Salzburg
      • Salzburg, State of Salzburg, Østerrike, 5020
        • Har ikke rekruttert ennå
        • Universitätsklinikum Salzburg
        • Hovedetterforsker:
          • Elmar Aigner
        • Ta kontakt med:
    • State of Vienna
      • Vienna, State of Vienna, Østerrike, 1090
      • Vienna, State of Vienna, Østerrike, 1030
      • Vienna, State of Vienna, Østerrike, 1160
    • Styria
      • Graz, Styria, Østerrike, 8036
        • Har ikke rekruttert ennå
        • Medizinische Universität Graz
        • Hovedetterforsker:
          • Peter Fickert
        • Ta kontakt med:
    • Tyrol
      • Innsbruck, Tyrol, Østerrike, 6020
        • Har ikke rekruttert ennå
        • Medizinische Universität Innsbruck
        • Ta kontakt med:
        • Hovedetterforsker:
          • Herbert Tilg
    • Upper Austria
      • Linz, Upper Austria, Østerrike, 4010
        • Har ikke rekruttert ennå
        • Ordensklinikum Linz - Barmherzige Schwestern
        • Ta kontakt med:
        • Hovedetterforsker:
          • Stephanie Hametner-Schreil
      • Linz, Upper Austria, Østerrike, 4020
        • Har ikke rekruttert ennå
        • Kepler Universitätsklinikum
        • Hovedetterforsker:
          • Alexander Moschen
        • Ta kontakt med:
      • Wels, Upper Austria, Østerrike, 4600
        • Har ikke rekruttert ennå
        • Klinikum Wels-Grieskirchen
        • Ta kontakt med:
        • Hovedetterforsker:
          • Harald Hofer

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Medical University of Vienna

Samarbeidspartnere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

18. mars 2026

Primær fullføring (Antatt)

1. desember 2040

Studiet fullført (Antatt)

1. desember 2040

Datoer for studieregistrering

Først innsendt

5. mai 2026

Først innsendt som oppfylte QC-kriteriene

16. mai 2026

Først lagt ut (Faktiske)

20. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

20. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2309/2025

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

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).

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere