Assessing treatment response in patients with primary biliary cholangitis
Macrophage Activation Marker sCD163 in PBC Patients - Assessment of Treatment Response to UDCA
This study is testing if certain blood markers can help predict how well a common treatment works for people newly diagnosed with primary biliary cholangitis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Aarhus Academic / other |
| Locations | 1 site (Aarhus C, Central Jutland) |
| Trial ID | NCT02931513 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of ursodeoxycholic acid (UDCA) in newly diagnosed patients with primary biliary cholangitis (PBC) by measuring specific biomarkers, sCD163 and sMR, which may predict treatment response. The study will involve collecting blood samples, conducting Fibroscan assessments, administering questionnaires, and performing liver biopsies to gather comprehensive data on patient health and treatment outcomes. By understanding the relationship between these biomarkers and treatment efficacy, the study seeks to improve management strategies for PBC patients who may not respond adequately to UDCA.
Who should consider this trial
Good fit: Ideal candidates for this study are newly diagnosed patients with primary biliary cholangitis who have not yet started treatment with UDCA.
Not a fit: Patients under 18 years, those with a life expectancy of less than 6 months, or those with liver cancer or cirrhosis from other causes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better prediction of treatment responses in PBC patients, allowing for more personalized and effective treatment plans.
How similar studies have performed: While there have been studies on treatment responses in PBC, the specific focus on sCD163 and sMR as predictive biomarkers represents a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Newly diagnosed with Primary biliary cholangitis * No treatment with UDCA Exclusion Criteria: * Patient under 18 years * Expected lifetime under 6 months * Expected liver transplantation within 6 months * Liver cancer * Cirrhosis from other causes
Where this trial is running
Aarhus C, Central Jutland
- Department of Hepatology and Gastroenterology, Aarhus University Hospital, Denmark — Aarhus C, Central Jutland, Denmark (Recruiting)
Study contacts
- Study coordinator: Lars Bossen, PhD-student
- Email: larsbossen@clin.au.dk
- Phone: +4522800676
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.