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
32 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 Antibodies (AMA) at a titer of 1:40 or higher
- Persistently normal Alkaline Phosphatase (ALP) levels
You will not qualify if you...
- Previously diagnosed with Primary Biliary Cholangitis, autoimmune hepatitis, or primary sclerosing cholangitis
- Currently receiving treatment with ursodeoxycholic acid, fibrates, biologics, immunosuppressants, or oral steroids
- Have contraindications for liver biopsy
- Have a debilitating disease or poor prognosis
- Are pregnant
AI-Screening
AI-Powered Screening
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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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