Clinical trial Recruiting at 1 site Observational Ages 18 and up

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 typeObservational
Ages18 Years and up
SexAll
Enrollment40 (estimated)
SponsorUniversity of Aarhus
Academic / other
Locations1 site (Aarhus C, Central Jutland)
StatusRecruiting
StartedSeptember 2016
Main results expectedJanuary 2031
Study endsSeptember 2031
Registry record updatedAugust 12, 2022
Trial IDNCT02931513 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

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.