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

N/ARecruitingNCT07205874

Hospital Universitario La Paz80 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Primary Biliary Cholangitis (PBC)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Signed informed consent * Positive AMA (≥1:40 titer) * Persistently normal ALP Exclusion Criteria: * Previously diagnosed with PBC, autoimmune hepatitis, or primary sclerosing cholangitis * Under treatment with ursodeoxycholic acid, fibrates, biologics or immunosuppressants including oral steroids * Contraindications for liver biopsy * Concomitant debilitating disease or poor prognosis * Pregnancy

Locations (1)

Hospital Universitario La Paz

Madrid, Spain