Program to find patients with Primary Biliary Cholangitis who have been lost to follow-up
Official title: Detection Program for Patients With Primary Biliary Cholangitis Lost in the System
Run by Hospital Mutua de Terrassa · NCT05919433 · Data updated 2026-11-12
This program is trying to find and help patients with Primary Biliary Cholangitis who have fallen out of regular care to improve their health and treatment outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Hospital Mutua de Terrassa Academic / other |
| Locations | 1 site (Terrassa, Barcelona) |
| Status | Recruiting |
| Started | May 1, 2023 |
| Main results expected | December 31, 2023 |
| Study ends | December 31, 2028 |
| Registry record updated | June 26, 2023 |
| Trial ID | NCT05919433 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this program are adults aged 18 and older with positive autoimmune markers for PBC.
✕Probably not a fit
Patients with Overlap Syndrome, which includes PBC combined with Autoimmune Hepatitis, may not benefit from this program.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational program aims to identify and manage patients with Primary Biliary Cholangitis (PBC) who have been lost in the healthcare system. PBC is a chronic liver disease that can lead to severe complications if not diagnosed and treated early. The program will focus on patients with specific autoimmune markers and will involve close monitoring and management strategies to improve patient outcomes. By enhancing early diagnosis and treatment adherence, the program seeks to address the challenges faced by PBC patients, particularly those who do not respond to standard therapies.
Why it matters
Potential benefit: If successful, this program could significantly improve early diagnosis and management of PBC, leading to better patient outcomes and survival rates.
How similar studies have gone: While there is limited information on similar programs specifically targeting lost patients, the approach of enhancing patient follow-up and management in chronic diseases has shown promise in other contexts.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with positive AMA and/or with positive ANA anti-gp210 or anti-sp100 identified in the computer databases of each of the participating centers. * Adults (≥18 years) Exclusion Criteria: * Patients with Overlap Syndrome (PBC overlap with Autoimmune Hepatitis (AIH))
Where it's running
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Hospital Universitari MútuaTerrassa
Terrassa, Barcelona, Spain Recruiting
Study contacts
- Study coordinator: Diana Horta, MD, PhD
- Email: diana.horta.s@gmail.com
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Seladelpar and Cilofexor in Primary Biliary Cholangitis (PBC)
This study tests whether combining seladelpar with cilofexor helps people with primary biliary cholangitis more than seladelpar alone or placebo.
-
Austrian PBC Registry
This registry follows adults with primary biliary cholangitis in Austrian centers to see how the disease develops over time and how biomarkers relate to complications and symptoms.
-
Biochemical response and health outcomes in people with primary biliary cholangitis
We will follow adults with primary biliary cholangitis who are taking ursodeoxycholic acid (UDCA) to see if their alkaline phosphatase levels after treatment predict how long they stay free of complications.
-
Saroglitazar Magnesium for PBC with incomplete UDCA response or intolerance
This study tests whether Saroglitazar Magnesium can help people with primary biliary cholangitis who still have high alkaline phosphatase despite UDCA or cannot take UDCA.
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CS0159 for primary biliary cholangitis when UDCA doesn't work or isn't tolerated.
This test tries to see if taking CS0159 once daily helps adults with primary biliary cholangitis who have an inadequate response to or cannot tolerate UDCA.
-
Saroglitazar Magnesium-V as add-on therapy for primary biliary cholangitis
This trial tests whether Saroglitazar Magnesium-V, compared with placebo, can improve long-term clinical outcomes in adults with primary biliary cholangitis who are on UDCA.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.