Finding Early Signs of Primary Biliary Cholangitis in Adults With Antibodies
Studies early diagnosis of a liver disease in adults with positive antibodies and normal ALP.
Plain-language title generated from the registry record
Registry title: Early Diagnosis of Primary Biliary Cholangitis (PBC) in Patients With Positive Anti-Mitochondrial Antibodies (AMA) and Normal Alkaline Phosphatase (ALP)
Key facts
- Where
- Madrid, SpainSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with a positive AMA blood test and a normal ALP level. They will have a liver biopsy and blood tests to look for early primary biliary cholangitis (PBC).
- Age
- 18 to 80 years
- Sex
- All sexes can join
- Disease stage
- People not yet diagnosed with PBC, who have a positive AMA and an ALP that has stayed normal.
- Earlier treatment
- People who are taking ursodeoxycholic acid, fibrates, biologics or immunosuppressants (including oral steroids) cannot join.
- Biomarker or test result
- Positive AMA (titer 1:40 or higher) and persistently normal ALP.
Main reasons for not taking part
- Already diagnosed with PBC, autoimmune hepatitis or primary sclerosing cholangitis
- Taking ursodeoxycholic acid, fibrates, biologics or immunosuppressants, including oral steroids
- Reasons that make a liver biopsy unsafe
- Another debilitating disease or poor prognosis
- Pregnancy
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07205874, who can take part
Where in Spain
- Hospital Universitario La PazMadrid, SpainContact: Antonio Olveira, DrTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Hospital Universitario La Paz
- Trial code
- NCT07205874
- Record updated
- 3 October 2025
- Original description
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:Read full original descriptionShow less
Early Diagnosis of Primary Biliary Cholangitis (PBC) in Patients With Positive Anti-Mitochondrial Antibodies (AMA) and Normal Alkaline Phosphatase (ALP)
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.
Inclusion: Signed informed consent; Positive AMA (≥1:40 titer); Persistently normal ALP.
Exclusion: 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; Contraindications for liver biopsy; Pregnancy.