Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Recruiting Observational

sCD163 in PBC Patients - Assessment of Treatment Response

NCT02931513 · tracked via the Priya Life Science Denmark tracker
Phase
Observational
Started
2016-09
Last updated
2022-08-12

Condition(s) studied

Primary Biliary CirrhosisLiver InflammationUrsodeoxycholic Acid

Investigational drug(s) / intervention(s)

Blood samplesFibroscanQuestionnairesLiver biopsy

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

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • UDCA response (ALP <3 times upper normal limit, AST <2 times upper normal limit, and bilirubin ≤1 mg/dL after one year of treatment) — 1 year

Trial sites (1)

FacilityCityRegionStatus
Department of Hepatology and Gastroenterology, Aarhus University Hospital, Denmark Aarhus C Central Jutland Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02931513 on ClinicalTrials.gov ↗ ← All trials in Denmark