Austrian PBC Registry

NCT07598669 | Recruiting

• 1 other identifier: 2309/2025
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 11

Brief Summary

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.

Conditions

Primary Biliary Cholangitis; Liver Cirrhosis; Portal Hypertension

Outcome Measures

Primary Outcomes (1)

• Transplant-free survival

  Time from inclusion to death or liver transplantation

  Through study completion, an average of 5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• Withdrawal of written informed consent

Sponsors & Collaborators

• Medical University of Vienna: lead
• 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

Study Sites (11)

Klinikum Klagenfurt am Wörthersee

Klagenfurt, Carinthia, 9020, Austria

NOT YET RECRUITING

Universitätsklinikum St. Pölten

Sankt Pölten, Lower Austria, 3100, Austria

NOT YET RECRUITING

Universitätsklinikum Salzburg

Salzburg, State of Salzburg, 5020, Austria

NOT YET RECRUITING

Klinik Landstraße

Vienna, State of Vienna, 1030, Austria

NOT YET RECRUITING

Medizinische Universität Wien

Vienna, State of Vienna, 1090, Austria

RECRUITING

Klinik Ottakring

Vienna, State of Vienna, 1160, Austria

NOT YET RECRUITING

Medizinische Universität Graz

Graz, Styria, 8036, Austria

NOT YET RECRUITING

Medizinische Universität Innsbruck

Innsbruck, Tyrol, 6020, Austria

NOT YET RECRUITING

Ordensklinikum Linz - Barmherzige Schwestern

Linz, Upper Austria, 4010, Austria

NOT YET RECRUITING

Kepler Universitätsklinikum

Linz, Upper Austria, 4020, Austria

NOT YET RECRUITING

Klinikum Wels-Grieskirchen

Wels, Upper Austria, 4600, Austria

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, serum, liver tissue

MeSH Terms

Conditions

Liver Cirrhosis, Biliary; Liver Cirrhosis; Hypertension, Portal

Condition Hierarchy (Ancestors)

Cholestasis, Intrahepatic; Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Liver Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Michael Trauner, MD

CONTACT

+43 1 40400 47410; Michael.Trauner@meduniwien.ac.at

Benedikt S Hofer, MD

CONTACT

+43 1 40400 47410; Benedikt.S.Hofer@meduniwien.ac.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Gastroenterology and Hepatology, Professor of Internal Medicine

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 20, 2026
• Study Start: March 18, 2026
• Primary Completion (Estimated): December 1, 2040
• Study Completion (Estimated): December 1, 2040
• Last Updated: May 20, 2026

Record last verified: 2026-05

Locations

AU (11)