Assessing treatment response in patients with primary biliary cholangitis
Official title: Macrophage Activation Marker sCD163 in PBC Patients - Assessment of Treatment Response to UDCA
Run by University of Aarhus · NCT02931513 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | University of Aarhus Academic / other |
| Locations | 1 site (Aarhus C, Central Jutland) |
| Status | Recruiting |
| Started | September 2016 |
| Main results expected | January 2031 |
| Study ends | September 2031 |
| Registry record updated | August 12, 2022 |
| Trial ID | NCT02931513 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are newly diagnosed patients with primary biliary cholangitis who have not yet started treatment with UDCA.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While there have been studies on treatment responses in PBC, the specific focus on sCD163 and sMR as predictive biomarkers represents a novel approach.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Non-invasive blood and imaging tests for metabolic liver disease
This project tests whether blood tests and imaging scans can diagnose and stage metabolic-associated steatohepatitis (MASH) and liver fibrosis in adults with metabolic risk factors.
-
Evaluating LivQ-box® for diagnosing liver inflammation
This study is testing if the LivQ-box® can help doctors better diagnose liver inflammation in people with nonalcoholic fatty liver disease.
-
Ursodeoxycholic acid helps prevent glucose intolerance in statin users
This study is testing if taking Ursodeoxycholic acid along with a common cholesterol medication can help people with high cholesterol avoid problems with blood sugar levels.
-
Identifying liver disease-specific gut microbiomes
This study is trying to find out if certain gut bacteria are linked to chronic liver diseases in adults, including autoimmune hepatitis and primary biliary cholangitis, by analyzing blood and stool samples from patients and their household members.
-
Biobank for cholestatic liver diseases
This study is collecting samples and health information from people with cholestatic liver diseases to see if it can help us better understand these conditions and improve how we detect and predict them.
-
Fenofibrate added to UDCA for people with primary biliary cirrhosis not fully responding to UDCA
This trial tests adding fenofibrate to UDCA for adults with primary biliary cirrhosis who did not fully respond to UDCA alone.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.