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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorHospital Universitario La Paz

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

Trial groups

80 Participants
are grouped into 1 trial group

Sponsors and collaborators