Patients With Primary Biliary Cholangitis(PBC) (NCT07629128) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Patients With Primary Biliary Cholangitis(PBC)
Italy30 participantsStarted 2026-05-18
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline to 3 months in glycated hemoglobin (HbA1c) levels (%)
Timeframe: 3-16 months
2
Change from baseline to 3 months in fasting plasma glucose levels (mg/dL)
Timeframe: 3-16 months
3
Change from baseline to 3 months in continuous glucose monitoring-derived time in range (%)