Status:
RECRUITING
Early Diagnosis of Primary Biliary Cholangitis (PBC) in Patients With Positive Anti-Mitochondrial Antibodies (AMA) and Normal Alkaline Phosphatase (ALP)
Lead Sponsor:
Hospital Universitario La Paz
Conditions:
Primary Biliary Cholangitis (PBC)
Eligibility:
All Genders
18-80 years
Brief 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 (A...
Eligibility Criteria
Inclusion
- Signed informed consent
- Positive AMA (≥1:40 titer)
- Persistently normal ALP
Exclusion
- 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
Key Trial Info
Start Date :
September 15 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT07205874
Start Date
September 15 2025
End Date
May 1 2026
Last Update
October 3 2025
Active Locations (1)
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1
Hospital Universitario La Paz
Madrid, Spain, 28046