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Spanish databases used to map a rare liver disease

NCT ID NCT07821463

Knowledge-focused Sponsor: Fundacio Privada Mon Clinic Barcelona Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 15, 2026 · Last updated Sep 16, 2026 · Updated 1 time

Summary

Primary biliary cholangitis is a rare liver disease that slowly damages the bile ducts and can lead to cirrhosis or a liver transplant. Researchers are studying anonymised health records from about 3,000 adults in four Spanish databases to estimate how many people have the disease, how many are newly diagnosed each year, and which treatments they receive. The study also tracks how often patients develop cirrhosis or need a transplant and which factors predict worse outcomes. No patients are contacted, and no extra tests or treatments are given.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If the study maps who gets PBC and how their disease progresses, it could help Spanish health planners target screening and care toward the people most at risk.
What could go wrong
This study only reads existing medical records, so it cannot prove what causes PBC or which treatment works best. Missing or inconsistent data across the four databases may limit how much the numbers can be trusted.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 3,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

primary biliary cholangitis primary biliary cholangitis 1

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

PBC Primary biliary cholangitis (PBC)

Contacts and locations

Locations

  • Hospital Clínic de Barcelona

    Barcelona, Spain

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