Using bezafibrate to treat patients with primary biliary cholangitis
Measuring Macrophage Activation Markers and Influence on Bile Acid Composition in Patients With Primary Biliary Cholangitis After Treatment With Bezafibrate
University of Aarhus · NCT04514965
This study is testing whether adding bezafibrate to the usual treatment can help people with primary biliary cholangitis who aren't getting better with standard medication.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | University of Aarhus (other) |
| Locations | 2 sites (Aarhus N, Central Jutland and 1 other locations) |
| Trial ID | NCT04514965 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the effects of bezafibrate, a PPAR-agonist, as an add-on therapy for patients with primary biliary cholangitis (PBC) who do not respond adequately to standard treatment with ursodeoxycholic acid (UDCA). The study will analyze how bezafibrate influences levels of macrophage activation markers, fibrosis markers, and bile acid composition in these patients. By identifying predictors of insufficient response to UDCA, the research aims to improve treatment outcomes for PBC patients. Blood sampling and Fibroscan will be utilized to gather necessary data.
Who should consider this trial
Good fit: Ideal candidates for this study are adults diagnosed with primary biliary cholangitis who are being offered bezafibrate treatment.
Not a fit: Patients with a life expectancy of less than six months, known cancer, or other liver diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with PBC who do not respond well to current therapies.
How similar studies have performed: While the use of bezafibrate in PBC is being explored, this approach is relatively novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * PBC patient offered bezafibrate treatment Exclusion Criteria: * patient age under 18 * life expectancy less than 6 months * known cancer * planned liver transplantation within 6 months * other liver disease (viral, autoimmune, alcohol, NAFLD/NASH)
Where this trial is running
Aarhus N, Central Jutland and 1 other locations
- Department of Hepatology and Gastroenterology, Aarhus University Hospital, Denmark — Aarhus N, Central Jutland, Denmark (RECRUITING)
- Department of Medicine, Gastrounit Medical division — Hvidovre, Denmark (RECRUITING)
Study contacts
- Principal investigator: Henning Grønbæk, Prof, MD — Aarhus University Hospital
- Study coordinator: Henning Grønbæk, Prof, MD
- Email: henngroe@rm.dk
- Phone: +45 21679281
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Primary Biliary Cirrhosis, Bezafibrate, Macrophage activation markers, Fibrosis markers, Bile acid composition