Program to find patients with Primary Biliary Cholangitis who have been lost to follow-up
Detection Program for Patients With Primary Biliary Cholangitis Lost in the System
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 |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Mutua de Terrassa Academic / other |
| Locations | 1 site (Terrassa, Barcelona) |
| Trial ID | NCT05919433 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this program are adults aged 18 and older with positive autoimmune markers for PBC.
Not a fit: Patients with Overlap Syndrome, which includes PBC combined with Autoimmune Hepatitis, may not benefit from this program.
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 performed: 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.
Eligibility criteria
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 this trial is running
Terrassa, Barcelona
- Hospital Universitari MútuaTerrassa — Terrassa, Barcelona, Spain (Recruiting)
Study contacts
- Study coordinator: Diana Horta, MD, PhD
- Email: diana.horta.s@gmail.com
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.