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

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

Recruiting
18-80 years
All
Phase N/A
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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.

Eligibility

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

Study details
    Primary Biliary Cholangitis (PBC)

NCT07205874

Hospital Universitario La Paz

16 October 2025

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