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Epidemiology of PrImary Biliary Cholangitis in Spain

Epidemiology of PrImary Biliary Cholangitis in Spain

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07821463
Acronym
EPIC-PBC
Enrollment
3000
Registered
2026-09-15
Start date
2026-02-11
Completion date
2027-08-01
Last updated
2026-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PBC, Primary Biliary Cholangitis (PBC)

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.

Interventions

None listed

Sponsors

Fundacio Privada Mon Clinic Barcelona
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Cross-sectional study (Incidence and prevalence of PBC): * Individuals aged 18 years included in any of the BIFAPSIDIAP, Galician or Andalusian databases. 2. Cohort study (Secondary aims): * Individuals aged 18 years and older, with PBC and included in any of the SIDIAP, Andalusian, or Galician databases.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Epidemiology of PBC in Spain15 monthsTo characterize the epidemiology of PBC in Spain by estimating its prevalence (cross-sectional study) and incidence (cohort study).

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 16, 2026