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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-15

Study Completion Date

2026-05-31

Brief Summary

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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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Detailed Description

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Conditions

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Primary Biliary Cholangitis (PBC)

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Case patients

Patientes aged 18-80 years, with positive AMA (≥1:40 titer) and persistently normal ALP

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No