RecruitingNCT02931513

sCD163 in PBC Patients - Assessment of Treatment Response

Macrophage Activation Marker sCD163 in PBC Patients - Assessment of Treatment Response to UDCA


Sponsor

University of Aarhus

Enrollment

40 participants

Start Date

Sep 1, 2016

Study Type

OBSERVATIONAL

Conditions

Summary

Primary biliary cholangitis (PBC) is an autoimmune chronic liver disease, characterised by destruction of the small intrahepatic bile ducts. Ursodeoxycholic acid (UDCA) is the first line treatment for patients with PBC. However, up to 40% of patients respond inadequate to this treatment. sCD163 is a macrophage activation marker shedded into plasma by macrophages in the liver. sMR is a soluble mannose receptor. The investigators want to investigate whether sCD163 and sMR can predict response to treatment with UDCA in newly diagnosed patients with PBC.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study measures a protein called sCD163 in the blood of newly diagnosed Primary Biliary Cholangitis (PBC) patients to see whether it can predict how well patients respond to standard treatment with UDCA (ursodeoxycholic acid). PBC is a chronic liver disease where the immune system attacks the bile ducts. A reliable blood marker for treatment response could help doctors personalize treatment earlier. You may be eligible if: - You are 18 years of age or older - You have been newly diagnosed with Primary Biliary Cholangitis (PBC) - You have not yet started treatment with UDCA You may NOT be eligible if: - You are under 18 years old - Your estimated life expectancy is less than 6 months - You are expected to need a liver transplant within 6 months - You have liver cancer - You have cirrhosis from a cause other than PBC Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERBlood samples
DEVICEFibroscan
OTHERQuestionnaires
BIOLOGICALLiver biopsy

Liver biopsy will only be obtained if obtained as part of the diagnosis (will not be obtained for study purpose only)


Locations(1)

Department of Hepatology and Gastroenterology, Aarhus University Hospital, Denmark

Aarhus C, Central Jutland, Denmark

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NCT02931513


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