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Study identifier: NCT05919433 Synced from ClinicalTrials.gov · July 29, 2026
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Detection Program for Patients With Primary Biliary Cholangitis Lost in the System

Condition: Primary Biliary Cholangitis  ·  Sponsor: Hospital Mutua de Terrassa

PhaseN/A
Planned participants500
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

Primary biliary cholangitis (PBC) has been considered a rare disease and its management has been limited by the lack of therapeutic alternatives. PBC is a slowly progressing chronic liver disease characterized by an immune-mediated destruction of the intrahepatic bile ducts, which leads to cholestasis, portal inflammation, and ultimately liver cirrhosis and its associated complications (ascites, portal hypertension, etc), if not treated effectively. Thus, early diagnosis and close management of these patients with PBC is essential. First-line treatment with ursodeoxycholic acid (UDCA) improves liver biochemical parameters, delays histological progression, and increases liver transplant-free survival and overall survival. However, up to 40% of patients are non-responders to UDCA. Obeticholic acid (OCA) is recommended as second-line therapy in combination with UDCA for patients with an inadequate response to UDCA or as monotherapy in cases of UDCA intolerance. According to current clinical guidelines, the diagnosis of PBC includes a combination of elevated alkaline phosphatase (ALP) levels and the presence of anti-mitochondrial antibodies (AMA) (titer \>1:40) and/or anti-nuclear antibodies (ANA) anti-gp210 or anti-sp100. AMA are highly sensitive and specific for PBC and are detected in nearly 95% of PBC patients. A liver biopsy is not necessary unless there is an elevation of ALP without the presence of specific AMA and/or anti-gp210 or anti-sp100 ANA or if coexistence with ot…

This description comes directly from the study's public registry record.

Talk to the study team

Diana Horta, MD, PhD  ·  diana.horta.s@gmail.com

Always discuss trial participation with your own doctor first.

Locations (1)

Hospital Universitari MútuaTerrassaTerrassa, Barcelona, SpainRecruiting

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Source record: clinicaltrials.gov/study/NCT05919433