sCD163 and sMR in Wilsons Disease - Associations With Disease Severity and Fibrosis

• Register: ClinicalTrials.gov
• Last refreshed on: 14 November 2022
• Main ID: NCT02702765
• Date of registration: 26/02/2016
• Prospective Registration: No
• Primary sponsor: University of Aarhus
• Public title: sCD163 and sMR in Wilsons Disease - Associations With Disease Severity and Fibrosis
• Scientific title: Macrophages and the Macrophage Activation Markers sCD163 and Mannose Receptor (sMR) in Patients With Wilsons Disease - Associations With Liver Disease Severity and Fibrosis
• Date of first enrolment: February 2016
• Target sample size: 33
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02702765
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Denmark

Contacts

• Name: Henning Grønbæk, Professor
• Affiliation: Aarhus University Hospital, Nørrebrogade 44, Aarhus C, Denmark, 8000

Key inclusion & exclusion criteria

Inclusion Criteria:

- diagnosed with Wilsons disease

Exclusion Criteria:

-



Age minimum: 18 Years
Age maximum: 100 Years
Gender: All

Health Condition(s) or Problem(s) studied

Wilsons Disease

Intervention(s)

Drug: Galactose

Procedure: Liver biopsy

Procedure: Fibroscan

Procedure: Ultrasound

Procedure: Functional hepatic nitrogen clearance

Primary Outcome(s)

Measurement of the macrophage activation markers sCD163 [Time Frame: Baseline, 1 year, 2 year, 3 year]

Measurement of soluble mannose receptor (sMR) [Time Frame: Baseline, 1 year, 2 year, 3 year]

Secondary Outcome(s)

The Portosystemic Encephalopathy to evaluate brain dysfunction [Time Frame: Baseline, 1 year, 2 year, 3 year]

Continous Reaction Time to evaluate brain dysfunction [Time Frame: Baseline, 1 year, 2 year, 3 year]

Functional hepatic nitrogen clearance to evaluate metabolic liver function [Time Frame: Baseline, 1 year, 2 year, 3 year]

Galactose elimination capacity is performed to evaluate metabolic liver function [Time Frame: Baseline, 1 year, 2 year, 3 year]

Fibroscan is performed to evaluate liver stiffness (fibrosis) [Time Frame: Baseline, 1 year, 2 year, 3 year]

Histological disease activity at time of diagnosis and liver biopsy, evaluating if any liver fibrosis [Time Frame: Baseline, 1 year, 2 year, 3 year]

Ultrasound is performed for signs of liver cirrhosis. [Time Frame: Baseline, 1 year, 2 year, 3 year]

Urinary copper excretion in 24 hour urine collection [Time Frame: Baseline, 1 year, 2 year, 3 year]

Secondary ID(s)

Wilson sCD163

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Aarhus University Hospital