PBCEPIC-PBCNCT07821463
Epidemiology of PrImary Biliary Cholangitis in Spain
An observational study of PBC and Primary Biliary Cholangitis (PBC), run by Fundacio Privada Mon Clinic Barcelona at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PBC, Primary Biliary Cholangitis (PBC)
- How many people
- 3,000 participants
- Where
- 1 siteSpain
- Study dates
- 11 Feb 2026to Aug 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults identified in Spanish healthcare databases and registries with a recorded diagnosis of PBC.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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?
Read more
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)
- Medical subject headings
- Liver Cirrhosis, Biliary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adult patients with primary biliary cholangitis (PBC) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epidemiology of PBC in Spain
To characterize the epidemiology of PBC in Spain by estimating its prevalence (cross-sectional study) and incidence (cohort study).
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start11 Feb 2026
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PBCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio Privada Mon Clinic Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07821463
- Sponsor's protocol ID
- EPIC-PBC
- Acronym
- EPIC-PBC
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No