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NCT Number: NCT07205874

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.

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Key information

Conditions

Primary Biliary Cholangitis (PBC) Bile Duct Diseases Biliary Tract Diseases Cholestasis Cholestasis, Intrahepatic Digestive System Diseases Fibrosis Liver Cirrhosis Liver Cirrhosis, Biliary Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Scheuer's criteria

    Time frame: Just once, at enrollment

    Liver biopsy samples

Secondary outcomes

  1. Enhanced Liver Fibrosis (ELF) Score

    Time frame: Just once, at enrollment

    Utilizes biomarkers such as hyaluronic acid, tissue inhibitor of metalloproteinase-1 (TIMP-1), and procollagen III amino-terminal peptide (PIIINP)

  2. Fibroblast Growth Factor 19 (FGF-19)

    Time frame: Just once, at enrollment

    Provides insights into bile acid regulation and metabolic liver function. Quantified using enzyme-linked immunosorbent assay (ELISA)

  3. Tumor Necrosis Factor-alpha (TNF-α)

    Time frame: Just once, at enrollment

    Measured via high-sensitivity ELISA to assess inflammatory status

  4. Cytokine Profiling (Interleukin-6, -12, -23)

    Time frame: Just once, at enrollment

    Serum cytokine levels will be determined using multiplex immunoassays

  5. Transforming Growth Factor-beta (TGF-β)

    Time frame: Just once, at enrollment

    Quantified via ELISA to evaluate its role in fibrosis and immune regulation

Sponsors and collaborators

Lead sponsor

Hospital Universitario La Paz

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 3, 2025
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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