Clinical Trial

Early Diagnosis of Primary Biliary Cholangitis (PBC) in Patients With Positive Anti-Mitochondrial Antibodies (AMA) and Normal Alkaline Phosphatase (ALP)

Recruiting
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Record status
This record was last updated October 3, 2025 (before its estimated March 2026 completion). Its status may not reflect the trial's current state.
Summary
The goal of this observational study is to achieve early diagnosis of Primary Biliary Cholangitis (PBC) in patients with positive Anti-Mitochondrial Antibodies (AMA) and Normal Alkaline Phosphatase (ALP) in adults aged 18-80 years with positive AMA and normal ALP. The main question it aims to answer is: • Are there any predictive factors for histological PBC in patients with positive AMA and normal ALP? Participants will undergo a liver biopsy and specific blood tests if eligible based on inclusion and exclusion criteria.
Trial Details
NCT Number NCT07205874
Lead Sponsor Hospital Universitario La Paz
Conditions Primary Biliary Cholangitis (PBC)
Enrollment 80 participants
Start Date 2025-09-15
Primary Completion 2026-03 (estimated)
Study Completion 2026-05 (estimated)
Updated on ClinicalTrials.gov 2025-10-03