Early Diagnosis of Primary Biliary Cholangitis (PBC) in Patients With Positive Anti-Mitochondrial Antibodies (AMA) and Normal Alkaline Phosphatase (ALP)
Hospital Universitario La Paz
80 participants
Sep 15, 2025
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- Signed informed consent
- Positive AMA (≥1:40 titer)
- Persistently normal ALP
Exclusion Criteria5
- 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
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Locations(1)
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NCT07205874