NCT07629128Active, not recruiting
Patients With Primary Biliary Cholangitis(PBC)
Metabolic Surveillance During PPAR-Agonist Treatment in Primary Biliary Cholangitis: New Perspectives for an Integrated Disease Management Approach.
Source: ClinicalTrials.gov · Last updated 5 Jun 2026
Brief summary (registry, in English)
Primary Biliary Cholangitis (PBC) is a chronic autoimmune cholestatic liver disease characterized by the progressive destruction of small intrahepatic bile ducts, leading to chronic cholestasis, hepatic fibrosis, and, in advanced stages, cirrhosis. Recent advances in the understanding of PBC pathophysiology have highlighted the central role of immune, inflammatory, and metabolic alterations in disease onset and progression.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 30 (estimated)
- First submitted
- 18 May 2026
- Start date
- May 2026
- Primary completion date
- May 2027
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Diseases
- Primary biliary cholangitis
- NCT number
- NCT07629128
What you commit to
- Study type: Observational
- Planned participants: 30
- From May 2026 to the primary completion date, May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with a prior diagnosis of diabetes mellitus currently on insulin therapy
- Patients on treatment known to significantly affect glycemic values (e.g., GLP-1 receptor agonists, SGLT2 inhibitors, systemic corticosteroids)
- Patients with a life expectancy or estimated time to liver transplantation of less than 6 months
Who the study is looking for
- Age ≥ 18 years
- Confirmed diagnosis of PBC (biochemical criteria, antibody positivity and/or histological examination)
- The patient is a candidate for first- or second-line PPAR agonist therapy, as clinical practice, for the treatment of PBC
- The patient requires comprehensive metabolic monitoring, as per clinical practice
- Signed the informed consent form
Age in the registry: 18 years to - · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione Policlinico Universitario A. Gemelli IRCCS,UOC Medicina Interna e Gastroenterologia,Largo A. Gemelli Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.