About this trial
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 criteria
Qualifiers
Signed informed consent
Positive AMA (≥1:40 titer)
Persistently normal ALP
Disqualifiers
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
Trial design
Treatments tested in this trial
- Not listed