Primary Biliary Cholangitis (PBC)NCT07205874
Early Diagnosis of Primary Biliary Cholangitis (PBC) in Patients With Positive Anti-Mitochondrial Antibodies (AMA) and Normal Alkaline Phosphatase (ALP)
An observational study of Primary Biliary Cholangitis (PBC), run by Hospital Universitario La Paz at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Primary Biliary Cholangitis (PBC)
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 15 Sep 2025to May 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults aged 18-80 years with positive AMA and normal ALP
Who may be able to join
- Signed informed consent
- Positive AMA (≥1:40 titer)
- Persistently normal ALP
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario La Paz
Madrid, 28046
Antonio Olveira, Dr, +34912071350, aolveiram@gmail.com
Laura García, MSc, +34912071350, eiiclapaz@gmail.com
About this study
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)
- Medical subject headings
- Liver Cirrhosis, Biliary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Case patients | Patientes aged 18-80 years, with positive AMA (≥1:40 titer) and persistently normal ALP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scheuer's criteria
Liver biopsy samples
Measured: Just once, at enrollment
Secondary outcomes (5)
Enhanced Liver Fibrosis (ELF) Score
Utilizes biomarkers such as hyaluronic acid, tissue inhibitor of metalloproteinase-1 (TIMP-1), and procollagen III amino-terminal peptide (PIIINP)
Measured: Just once, at enrollment
Fibroblast Growth Factor 19 (FGF-19)
Provides insights into bile acid regulation and metabolic liver function. Quantified using enzyme-linked immunosorbent assay (ELISA)
Measured: Just once, at enrollment
Tumor Necrosis Factor-alpha (TNF-α)
Measured via high-sensitivity ELISA to assess inflammatory status
Measured: Just once, at enrollment
Cytokine Profiling (Interleukin-6, -12, -23)
Serum cytokine levels will be determined using multiplex immunoassays
Measured: Just once, at enrollment
Transforming Growth Factor-beta (TGF-β)
Quantified via ELISA to evaluate its role in fibrosis and immune regulation
Measured: Just once, at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start15 Sep 2025
- Primary completionMar 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Biliary Cholangitis (PBC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María Dolores Martín Arranz, PhD, Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07205874
- Sponsor's protocol ID
- PI-6171
- Status last verified
- Sep 2025
- First submitted
- 25 Sep 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided