Actively Recruiting
Early Diagnosis of Primary Biliary Cholangitis (PBC) in Patients With Positive Anti-Mitochondrial Antibodies (AMA) and Normal Alkaline Phosphatase (ALP)
Led by Hospital Universitario La Paz · Updated on 2025-10-03
80
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying Primary Biliary Cholangitis (PBC) in adults aged 18 to 80 years who have positive Anti-Mitochondrial Antibodies (AMA) but normal levels of Alkaline Phosphatase (ALP). The goal is to identify early signs of PBC by looking for factors that may predict the disease in this group. This observational study focuses on finding ways to diagnose PBC before it progresses, which is important for timely care. Eligible participants are adults with positive AMA at a titer of 1:40 or higher and consistently normal ALP levels. During the study, participants may undergo a liver biopsy and specific blood tests to assess liver health and immune activity. These tests include reviewing liver tissue according to Scheuer's criteria and measuring markers like the Enhanced Liver Fibrosis (ELF) Score, Fibroblast Growth Factor 19, Tumor Necrosis Factor-alpha, cytokines, and Transforming Growth Factor-beta. Participants will be evaluated once at enrollment with these tests and biopsy to gather detailed information about their liver condition. The study collects samples and performs analyses to understand the presence and progression of PBC in people with positive AMA but normal liver enzymes. The findings aim to improve early diagnosis and monitoring approaches for patients who may develop this disease.
CONDITIONS
Brief Title
Early Diagnosis of Primary Biliary Cholangitis (PBC) in Patients With Positive Anti-Mitochondrial Antibodies (AMA) and Normal Alkaline Phosphatase (ALP)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Positive Anti-Mitochondrial Antibody (AMA) with a titer of 1:40 or higher
- Persistently normal levels of Alkaline Phosphatase (ALP)
You will not qualify if you...
- Previously diagnosed with Primary Biliary Cholangitis (PBC), autoimmune hepatitis, or primary sclerosing cholangitis
- Currently treated with ursodeoxycholic acid, fibrates, biologics, or immunosuppressants including oral steroids
- Contraindications for liver biopsy
- Presence of debilitating disease or poor prognosis
- Pregnant at the time of enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At enrollment
Participants undergo diagnostic assessments including liver biopsy and blood tests to evaluate liver condition and biomarker levels.
1 visit (in-person)
Duration - Up to study completion
Participants with positive Anti-Mitochondrial Antibody and normal Alkaline Phosphatase are observed over time to monitor liver health without active intervention.
Visits as scheduled by the study team
Trial Site Locations
Total: 1 location
1
Hospital Universitario La Paz
Madrid, Spain, 28046
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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