Epidemiology of PrImary Biliary Cholangitis in Spain

NCT07821463 | Active Not Recruiting

• 1 other identifier: EPIC-PBC
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

Primary biliary cholangitis (PBC) is a rare, long-term liver disease that can slowly damage the bile ducts, eventually leading to cirrhosis and, in some cases, the need for a liver transplant. The goal of this non-interventional, multi-database study is to characterize the epidemiology of PBC in Spain by estimating its prevalence (cross-sectional study) and incidence (cohort study).The main question it aims to answer is:

• What is the prevalence of PBC in Spain on a specific index date (31 December 2025)?
• What is the annual incidence of newly diagnosed PBC in Spain?
• How many patients with PBC receive first-line and second-line therapies in routine clinical practice?
• What proportion of patients with PBC develop cirrhosis and/or require liver transplantation, and how long does it take for these events to occur after diagnosis?
• Which factors are associated with poorer outcomes in patients with PBC? Researchers will use anonymised information from several large Spanish databases (BIFAP, SIDIAP, the Andalusian PBC Registry and the Spain RDR-Galicia registry) to identify adults with and without PBC and follow them over time. No patients will be contacted directly or asked to attend any study visits, and no additional tests or treatments will be carried out. All information will come from routinely collected healthcare data on adults with a diagnosis of PBC, which will be fully anonymised before analysis.

Conditions

PBC; Primary Biliary Cholangitis (PBC)

Outcome Measures

Primary Outcomes (1)

• Epidemiology of PBC in Spain

  To characterize the epidemiology of PBC in Spain by estimating its prevalence (cross-sectional study) and incidence (cohort study).

  15 months

Study Arms (1)

Adult patients with primary biliary cholangitis (PBC)

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

Adults identified in Spanish healthcare databases and registries with a recorded diagnosis of PBC.

You may qualify if:

• Cross-sectional study (Incidence and prevalence of PBC):
• Individuals aged 18 years included in any of the BIFAPSIDIAP, Galician or Andalusian databases.
• Cohort study (Secondary aims):
• Individuals aged 18 years and older, with PBC and included in any of the SIDIAP, Andalusian, or Galician databases.

You may not qualify if:

• Patients with other causes of liver disease (including, but not limited to, alcohol liver disease, steatotic liver disease, viral hepatitis, etc) will be excluded from the study.
• Incomplete or invalid records.

Sponsors & Collaborators

• Fundacio Privada Mon Clinic Barcelona: lead

Study Sites (1)

Hospital Clínic de Barcelona

Barcelona, Spain

Location

MeSH Terms

Conditions

Liver Cirrhosis, Biliary

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2026
• First Posted: September 15, 2026
• Study Start: February 11, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: September 15, 2026

Record last verified: 2026-09

Locations

ES (1)