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

NCT07205874 | Recruiting

• 1 other identifier: PI-6171
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Biliary Cholangitis (PBC)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Scheuer's criteria

  Liver biopsy samples

  Just once, at enrollment

Secondary Outcomes (5)

• Enhanced Liver Fibrosis (ELF) Score

  Just once, at enrollment

• Fibroblast Growth Factor 19 (FGF-19)

  Just once, at enrollment

• Tumor Necrosis Factor-alpha (TNF-α)

  Just once, at enrollment

• Cytokine Profiling (Interleukin-6, -12, -23)

  Just once, at enrollment

• Transforming Growth Factor-beta (TGF-β)

  Just once, at enrollment

Study Arms (1)

Case patients

Patientes aged 18-80 years, with positive AMA (≥1:40 titer) and persistently normal ALP

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults aged 18-80 years with positive AMA and normal ALP

You may qualify if:

• Signed informed consent
• Positive AMA (≥1:40 titer)
• Persistently normal ALP

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitario La Paz: lead

Study Sites (1)

Hospital Universitario La Paz

Madrid, 28046, Spain

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Liver biopsy samples

MeSH Terms

Conditions

Liver Cirrhosis, Biliary

Condition Hierarchy (Ancestors)

Cholestasis, Intrahepatic; Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Liver Diseases; Liver Cirrhosis; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of department

Study Record Dates

• First Submitted: September 25, 2025
• First Posted: October 3, 2025
• Study Start: September 15, 2025
• Primary Completion: March 1, 2026
• Study Completion: May 1, 2026
• Last Updated: October 3, 2025

Record last verified: 2025-09

Locations

ES (1)