Actively Recruiting
Measuring Macrophage Activation Markers and Bile Acid Changes in Primary Biliary Cholangitis Patients Treated With Bezafibrate
Led by University of Aarhus · Updated on 2022-08-12
100
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Aarhus
Lead Sponsor
A
Aarhus University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Primary biliary cholangitis (PBC) is an autoimmune liver disease that damages bile ducts and can lead to liver fibrosis and cirrhosis. Researchers are studying how adding bezafibrate, a drug that activates certain receptors called PPARs, affects markers of inflammation, liver fibrosis, and bile acid composition in PBC patients who do not respond fully to the standard treatment ursodeoxycholic acid (UDCA). This study aims to better understand the impact of bezafibrate on disease progression and inflammation markers in these patients. Participants in this study are PBC patients who are offered bezafibrate as an add-on treatment to UDCA. Patients begin bezafibrate treatment and have visits before starting and then at 4 weeks, 6 months, 1 year, 2 years, and 3 years after inclusion. During these visits, blood samples are collected, liver stiffness is measured using FibroScan, and patients are asked about itching (pruritus). Throughout the study, researchers will monitor changes in macrophage activation markers like sCD163, fibrosis markers, liver stiffness, and bile acid profiles over up to 3 years. They will also assess how bezafibrate affects itching symptoms. This long-term observation helps evaluate how bezafibrate influences liver inflammation, fibrosis, and bile acid composition in PBC, contributing to understanding treatment effects and potential targets for therapy.
CONDITIONS
Brief Title
Bezafibrate in Patients With Primary Biliary Cholangitis (PBC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- PBC patient offered bezafibrate treatment
You will not qualify if you...
- Age under 18 years
- Life expectancy less than 6 months
- Known cancer
- Planned liver transplantation within 6 months
- Other liver diseases such as viral hepatitis, autoimmune liver disease, alcohol-related liver disease, or fatty liver disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 years
Participants who start bezafibrate treatment are monitored through blood sampling, liver stiffness measurement using FibroScan, and questions about pruritus.
Visits at baseline, 4 weeks, 6 months, 1 year, 2 years, and 3 years after inclusion
Trial Site Locations
Total: 2 locations
1
Department of Hepatology and Gastroenterology, Aarhus University Hospital, Denmark
Aarhus N, Central Jutland, Denmark, 8200
Actively Recruiting
2
Department of Medicine, Gastrounit Medical division
Hvidovre, Denmark, 2650
Actively Recruiting
Research Team
H
Henning Grønbæk, Prof, MD
L
Lars Bossen, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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