NCT07821463Active, not recruiting
Epidemiology of PrImary Biliary Cholangitis in Spain
Source: ClinicalTrials.gov · Last updated 15 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 3000 (estimated)
- First submitted
- 10 Sept 2026
- Start date
- 11 Feb 2026
- Primary completion date
- Aug 2027
- Lead sponsor
- Fundacio Privada Mon Clinic Barcelona
- Diseases
- Primary biliary cholangitis
- NCT number
- NCT07821463
What you commit to
- Study type: Observational
- Planned participants: 3000
- From 11 Feb 2026 to the primary completion date, Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Incomplete or invalid records.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.