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OpenTrials
Active, not recruiting

NCT Number: NCT07821463

Epidemiology of PrImary Biliary Cholangitis in Spain

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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.

Treatment and study plan

Primary outcomes

  1. Epidemiology of PBC in Spain

    Time frame: 15 months

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

Sponsors and collaborators

Lead sponsor

Fundacio Privada Mon Clinic Barcelona

Other

Registry information

Acronym: EPIC-PBC

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 15, 2026
Registry last updated
Sep 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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