NCT07205874Recruiting
Early Diagnosis of Primary Biliary Cholangitis (PBC) in Patients With Positive Anti-Mitochondrial Antibodies (AMA) and Normal Alkaline Phosphatase (ALP)
Source: ClinicalTrials.gov · Last updated 3 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 80 (estimated)
- First submitted
- 25 Sept 2025
- Start date
- 15 Sept 2025
- Primary completion date
- Mar 2026
- Lead sponsor
- Hospital Universitario La Paz
- Diseases
- Primary biliary cholangitis
- NCT number
- NCT07205874
What you commit to
- Study type: Observational
- Planned participants: 80
- From 15 Sept 2025 to the primary completion date, Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previously diagnosed with PBC, autoimmune hepatitis, or primary sclerosing cholangitis
- Under treatment with ursodeoxycholic acid, fibrates, biologics or immunosuppressants including oral steroids
- Concomitant debilitating disease or poor prognosis
Other
- Contraindications for liver biopsy
- Pregnancy
Who the study is looking for
- Signed informed consent
- Positive AMA (≥1:40 titer)
- Persistently normal ALP
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.