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

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Signed informed consent

• Positive AMA (≥1:40 titer)

• Persistently normal ALP

Locations
Other Locations
Spain
Hospital Universitario La Paz
RECRUITING
Madrid
Time Frame
Start Date: 2025-09-15
Estimated Completion Date: 2026-05
Participants
Target number of participants: 80
Treatments
Case patients
Patientes aged 18-80 years, with positive AMA (≥1:40 titer) and persistently normal ALP
Sponsors
Leads: Hospital Universitario La Paz

This content was sourced from clinicaltrials.gov