Early Diagnosis of Primary Biliary Cholangitis (PBC) in Patients With Positive Anti-Mitochondrial Antibodies (AMA) and Normal Alkaline Phosphatase (ALP)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07205874

Enrollment

Registered

2025-10-03

Start date

2025-09-15

Completion date

2026-05-31

Last updated

2025-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Biliary Cholangitis (PBC)

Keywords

Primary Biliary Cholangitis (PBC), Anti-Mitochondrial Antibodies (AMA), Alkaline Phosphatase (ALP)

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Scheuer's criteria	Just once, at enrollment	Liver biopsy samples

Secondary

Measure	Time frame	Description
Enhanced Liver Fibrosis (ELF) Score	Just once, at enrollment	Utilizes biomarkers such as hyaluronic acid, tissue inhibitor of metalloproteinase-1 (TIMP-1), and procollagen III amino-terminal peptide (PIIINP)
Fibroblast Growth Factor 19 (FGF-19)	Just once, at enrollment	Provides insights into bile acid regulation and metabolic liver function. Quantified using enzyme-linked immunosorbent assay (ELISA)
Tumor Necrosis Factor-alpha (TNF-α)	Just once, at enrollment	Measured via high-sensitivity ELISA to assess inflammatory status
Cytokine Profiling (Interleukin-6, -12, -23)	Just once, at enrollment	Serum cytokine levels will be determined using multiplex immunoassays
Transforming Growth Factor-beta (TGF-β)	Just once, at enrollment	Quantified via ELISA to evaluate its role in fibrosis and immune regulation

Countries

Spain

Outcome results