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

Recruiting

• Conditions: Primary Biliary Cholangitis (PBC)

• Registration Number: NCT07205874
• Lead Sponsor: Hospital Universitario La Paz

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study Start: 2025-09-15
• Study First Submitted: 2025-09-25
• Study First Submitted QC: 2025-09-25
• Last Update Submitted: 2025-09-25
• Study First Posted: 2025-10-03
• Last Update Posted: 2025-10-03
• Primary Completion: 2026-03
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Scheuer's criteria	Just once, at enrollment	Liver biopsy samples

Secondary Outcome Measures

Name	Time	Method
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)
Tumor Necrosis Factor-alpha (TNF-α)	Just once, at enrollment	Measured via high-sensitivity ELISA to assess inflammatory status
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)
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

Trial Locations

Locations (1)

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain