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

Recruitingn/aAges 18 Years - 80 YearsAllHospital Universitario La Paz
NCT07205874 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Not listed
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Where

1 site
Hospital Universitario La Paz
Madrid, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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