NCT04514965 Bezafibrate in Patients With Primary Biliary Cholangitis (PBC)
| NCT ID | NCT04514965 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Aarhus |
| Condition | Primary Biliary Cirrhosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2020-10-01 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2020-10-01 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Up to 40% of patients with PBC have an inadequate response to standard treatment with UDCA, hence bezafibrate, a PPAR-agonist is being introduced as add-on therapy in these patients. sCD163, fibrosis markers and bile acid composition are of special interest in PBC. In this study, the investigators will investigate how treatment with bezafibrate influence levels of macrophage activation markers and fibrosis markers as well as bile acid composition in patients offered bezafibrate as add-on therapy to UDCA.
Eligibility 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)
Contact & Investigator
Henning Grønbæk, Prof, MD
PRINCIPAL INVESTIGATOR
Aarhus University Hospital
Frequently Asked Questions
Who can join the NCT04514965 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Primary Biliary Cirrhosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04514965 currently recruiting?
Yes, NCT04514965 is actively recruiting participants. Contact the research team at henngroe@rm.dk for enrollment information.
Where is the NCT04514965 trial being conducted?
This trial is being conducted at Aarhus N, Denmark, Hvidovre, Denmark.
Who is sponsoring the NCT04514965 clinical trial?
NCT04514965 is sponsored by University of Aarhus. The principal investigator is Henning Grønbæk, Prof, MD at Aarhus University Hospital. The trial plans to enroll 100 participants.