Early Diagnosis of Primary Biliary Cholangitis (PBC) in Patients With Positive Anti-Mitochondrial Antibodies (AMA) and Normal Alkaline Phosphatase (ALP)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Primary Biliary Cholangitis (PBC). Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Scheuer's criteria [Time frame: Just once, at enrollment]
Secondary outcome measures (5)
- Enhanced Liver Fibrosis (ELF) Score [Time frame: Just once, at enrollment]
- Fibroblast Growth Factor 19 (FGF-19) [Time frame: Just once, at enrollment]
- Tumor Necrosis Factor-alpha (TNF-α) [Time frame: Just once, at enrollment]
- Cytokine Profiling (Interleukin-6, -12, -23) [Time frame: Just once, at enrollment]
- Transforming Growth Factor-beta (TGF-β) [Time frame: Just once, at enrollment]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Spain · 1 center
- Hospital Universitario La Paz — Madrid
Identifiers
NCT: NCT07205874 · PI-6171