Clinical Trial

Patients With Primary Biliary Cholangitis

Study acronym: BILIFLEX
Active, Not Recruiting
View on ClinicalTrials.gov →
Summary
Primary biliary cholangitis (PBC) is a chronic autoimmune disease characterized by progressive destruction of the small intrahepatic bile ducts, leading to cholestasis and potential progression to cirrhosis. Prognosis is favorable when diagnosed and treated early, while diagnostic delay is common. Diagnosis is based on elevated ALP and the presence of autoantibodies (AMA/ANA), but the disease is often asymptomatic and detected late.It predominantly affects women aged 40-60 years, and evidence suggests underdiagnosis, highlighting the need for screening strategies in at-risk populations.
Trial Details
NCT Number NCT07573514
Lead Sponsor Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions Primary Biliary Cholangitis, Intrahepatic Bile Duct Cancer, Cancer Liver
Enrollment 2,000 participants
Start Date 2026-04-23
Primary Completion 2026-12 (estimated)
Study Completion 2027-04 (estimated)
Updated on ClinicalTrials.gov 2026-05-07