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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Diagnosis of Primary Biliary Cholangitis (PBC) in Patients With Positive Anti-Mitochondrial Antibodies (AMA) and Normal Alkaline Phosphatase (ALP)
- ClinicalTrials.gov ID
- NCT07205874
- Acronym / sponsor ID
- PI-6171
- Conditions
- Primary Biliary Cholangitis (PBC)
- Keywords
- Primary Biliary Cholangitis (PBC), Anti-Mitochondrial Antibodies (AMA), Alkaline Phosphatase (ALP)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hospital Universitario La PazUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 3 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Case patients | – | –Patientes aged 18-80 years, with positive AMA (≥1:40 titer) and persistently normal ALP |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 18-80 years with positive AMA and normal ALP
Key inclusion criteria (3 listed)
- Signed informed consent
- Positive AMA (≥1:40 titer)
- Persistently normal ALP
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Scheuer's criteria
Time frame: Just once, at enrollment
Liver biopsy samples
5 secondary outcomes
Enhanced Liver Fibrosis (ELF) Score
Time frame: Just once, at enrollment
Fibroblast Growth Factor 19 (FGF-19)
Time frame: Just once, at enrollment
Tumor Necrosis Factor-alpha (TNF-α)
Time frame: Just once, at enrollment
Cytokine Profiling (Interleukin-6, -12, -23)
Time frame: Just once, at enrollment
Transforming Growth Factor-beta (TGF-β)
Time frame: Just once, at enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Biliary Cholangitis (PBC), run by Hospital Universitario La Paz at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scheuer's criteria (time frame: Just once, at enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.