Clinical trial Recruiting at 1 site Observational Ages 18 and up

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 typeObservational
Ages18 Years and up
SexAll
Enrollment500 (estimated)
SponsorHospital Mutua de Terrassa
Academic / other
Locations1 site (Terrassa, Barcelona)
StatusRecruiting
StartedMay 1, 2023
Main results expectedDecember 31, 2023
Study endsDecember 31, 2028
Registry record updatedJune 26, 2023
Trial IDNCT05919433 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

  • Hospital Universitari MútuaTerrassa
    Terrassa, Barcelona, Spain
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • 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.

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  • 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.

    Recruiting Medical University of Vienna · Klagenfurt, Carinthia and 10 other locations · NCT07598669

  • 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.

    Recruiting RenJi Hospital · Shanghai, Shanghai Municipality · NCT07449793

  • 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.

    Recruiting Phase 3 Zydus Therapeutics Inc. · Lakewood Rch, Florida · NCT07424677

  • 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.

    Recruiting at 39 sites Phase 3 Cascade Pharmaceuticals, Inc · Hefei, Anhui and 41 other locations · NCT07282353

  • 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.

    Recruiting at 3 sites Phase 3 Zydus Therapeutics Inc. · Marietta, Georgia and 2 other locations · NCT07216235

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.