Early detection of primary biliary cholangitis in people with positive AMA and normal ALP

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational, single-center study enrolling adults 18-80 with positive anti-mitochondrial antibodies (AMA) and persistently normal alkaline phosphatase (ALP). Eligible participants undergo specific blood tests and a liver biopsy to look for histological signs of PBC. Researchers will compare clinical and laboratory features to identify factors that predict histological PBC in this group. Patients already diagnosed with autoimmune liver disease or on relevant treatments are excluded.

Why it matters

Who can join: the full rules

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

Where it's running

• Hospital Universitario La Paz
  Madrid, Spain Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.