An observational study in Primary Biliary Cholangitis (PBC), sponsored by Hospital Universitario La Paz. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-10-03.
Sponsored by Hospital Universitario La Paz · Observational
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:
214 studies on the registry are indexed under Liver Cirrhosis, Biliary; 48 are open to participants now.
This study's planned enrollment of 80 is below the median of 380 across 54 observational studies indexed under Liver Cirrhosis, Biliary.
Browse Liver Cirrhosis, Biliary studies →Hospital Universitario La Paz is the lead sponsor of 56 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adults aged 18-80 years with positive AMA and normal ALP
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patientes aged 18-80 years, with positive AMA (≥1:40 titer) and persistently normal ALP
Scheuer's criteria
Liver biopsy samples
Time frame: Just once, at enrollment
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)
Time frame: 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)
Time frame: Just once, at enrollment
Tumor Necrosis Factor-alpha (TNF-α)
Measured via high-sensitivity ELISA to assess inflammatory status
Time frame: Just once, at enrollment
Cytokine Profiling (Interleukin-6, -12, -23)
Serum cytokine levels will be determined using multiplex immunoassays
Time frame: Just once, at enrollment
Transforming Growth Factor-beta (TGF-β)
Quantified via ELISA to evaluate its role in fibrosis and immune regulation
Time frame: Just once, at enrollment
Plan to share: Undecided
No publications or documents are linked to this record.
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Hospital Universitario La Paz