Austrian PBC Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMedical University of Vienna
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Withdrawal of written informed consent
Trial population
Patient with primary biliary cholangitis diagnosed and/or treated at one of the participating centers in Austria will be screened for inclusion/exclusion criteria.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Transplant-free survival
Time from inclusion to death or liver transplantation
Time frame
Through study completion, an average of 5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Medical University of Vienna
Lead sponsor
Klinik Ottakring
Collaborator
Medical University of Graz
Collaborator
Salzburger Universitätsklinkum
Collaborator
Universitätsklinikum St. Pölten
Collaborator
Kepler University Hospital
Collaborator
Klinikum Klagenfurt am Wörthersee
Collaborator
Klinikum Wels-Grieskirchen
Collaborator
Medical University Innsbruck
Collaborator
Ordensklinikum Linz GmbH Krankenhaus Barmherzige Schwestern
Collaborator
Krankenanstalt Rudolfstiftung
Collaborator
Source ClinicalTrials.gov