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

RECRUITINGSponsored by Hospital Universitario La Paz
Actively Recruiting
SponsorHospital Universitario La Paz
Started2025-09-15
Est. completion2026-03
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07205874

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

Age: 18 Years – 80 YearsHealthy volunteers accepted
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

Conditions2

Liver DiseasePrimary Biliary Cholangitis (PBC)

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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