Early detection of primary biliary cholangitis in people with positive AMA and normal ALP
Early Diagnosis of Primary Biliary Cholangitis (PBC) in Patients With Positive Anti-Mitochondrial Antibodies (AMA) and Normal Alkaline Phosphatase (ALP)
This project will test whether clinical features, blood markers, or a liver biopsy can identify early PBC in adults (18-80) who have positive AMA but normal ALP.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Hospital Universitario La Paz Academic / other |
| Locations | 1 site (Madrid) |
| Trial ID | NCT07205874 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18-80 with positive AMA (≥1:40) and persistently normal ALP who can safely undergo liver biopsy and are not currently treated for PBC or other autoimmune liver diseases.
Not a fit: People already diagnosed with PBC or other autoimmune liver diseases, those taking ursodeoxycholic acid, fibrates, biologics or immunosuppressants, pregnant people, or anyone who cannot safely have a liver biopsy are unlikely to benefit.
Why it matters
Potential benefit: If successful, the findings could enable earlier diagnosis of PBC so treatment can be started sooner to slow disease progression.
How similar studies have performed: Previous observational reports have detected histological PBC in some AMA-positive, ALP-normal individuals, but consistent predictive factors remain unestablished.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Madrid
- Hospital Universitario La Paz — Madrid, Spain (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.