Actively Recruiting
Macrophage Activation Marker sCD163 in PBC Patients - Assessment of Treatment Response to UDCA
Led by University of Aarhus · Updated on 2022-08-12
40
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Primary biliary cholangitis (PBC) is an autoimmune liver disease that causes damage to the small bile ducts inside the liver, leading to inflammation and possible progression to liver fibrosis and cirrhosis. Fatigue and itching are common symptoms that affect quality of life. This research aims to study the role of two markers, sCD163 and sMR, which are released by activated macrophages in the liver, to see if they can predict how well newly diagnosed PBC patients respond to the standard treatment with ursodeoxycholic acid (UDCA). The study monitors patients newly diagnosed with PBC who have not yet started UDCA treatment. Researchers collect blood samples, perform Fibroscan imaging, and use questionnaires to assess disease progression over three years. Liver biopsies will only be reviewed if done as part of diagnosis, not solely for the study. The main focus is to determine if sCD163 and sMR levels measured before treatment can identify patients who might not respond well to UDCA and who may need additional therapies. Participants will be followed for at least one year to evaluate their response to UDCA based on blood test results, including liver enzyme levels and bilirubin. Further assessments such as blood tests, Fibroscan, and questionnaires will be done over three years to track disease progression. The study does not include treatment administration but observes patients receiving usual care while measuring these markers and clinical outcomes.
CONDITIONS
Brief Title
sCD163 in PBC Patients - Assessment of Treatment Response
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed with Primary biliary cholangitis
- No prior treatment with ursodeoxycholic acid (UDCA)
- Age 18 years or older
You will not qualify if you...
- Patient under 18 years old
- Expected lifetime under 6 months
- Expected liver transplantation within 6 months
- Presence of liver cancer
- Cirrhosis caused by factors other than primary biliary cholangitis
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 - Up to diagnosis
Participants undergo diagnostic evaluations including blood samples, Fibroscan, questionnaires, and liver biopsy if obtained as part of diagnosis.
1 to 2 visits depending on procedures needed
Duration - Up to 3 years
Participants who receive routine treatment with ursodeoxycholic acid (UDCA) are observed to assess treatment response and disease progression.
Periodic visits for blood samples, Fibroscan, and questionnaires as scheduled
Trial Site Locations
Total: 1 location
1
Department of Hepatology and Gastroenterology, Aarhus University Hospital, Denmark
Aarhus C, Central Jutland, Denmark, 8000
Actively Recruiting
Research Team
L
Lars Bossen, PhD-student
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here