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

Madrid Health Service

Status: Enrolling

Conditions: Primary Biliary Cholangitis (PBC)

Study type: Observational

Funder types: Other

Identifiers

NCT07205874

PI-6171

Details and patient eligibility

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed informed consent
• Positive AMA (≥1:40 titer)
• Persistently normal ALP

Exclusion criteria

• 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

Trial design

80 participants in 1 patient group

Case patients

Description:

Patientes aged 18-80 years, with positive AMA (≥1:40 titer) and persistently normal ALP