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

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ClinicalTrials.gov Identifier: NCT02702765
Recruitment Status : Recruiting
First Posted : March 9, 2016
Last Update Posted : May 2, 2018
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:
The aim is to investigate macrophage activation markers and correlations to liver fibrosis in patients with Wilsons Disease. Researchers wish to investigate associations to neurologic and metabolic liver function. Researchers will assess this by comparing blood samples with fibrosis and liver function analyses. This study provides new insight into macrophages and their involvement in Wilsons Disease.

Condition or disease Intervention/treatment Phase
Wilsons Disease Procedure: Fibroscan Procedure: Ultrasound Drug: Galactose Procedure: Liver biopsy Procedure: Functional hepatic nitrogen clearance Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 33 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Macrophages and the Macrophage Activation Markers sCD163 and Mannose Receptor (sMR) in Patients With Wilsons Disease - Associations With Liver Disease Severity and Fibrosis
Actual Study Start Date : February 2016
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Wilson Disease

Arm Intervention/treatment
Experimental: Wilsons disease
All patients will receive all interventions (galactose elimination capacity test , ultrasound, fibroscan, continuous reaction time test and functional hepatic nitrogen clearance ), except liver biopsy.
Procedure: Fibroscan
Liver fibrosis will be determined using fibroscan, and reported as changes in the amount of fibrosis in the liver. The fibroscan is a non-invasive procedure

Procedure: Ultrasound
Ultrasound is a non-invasive procedure

Drug: Galactose

Galactose elimination capacity is performed to evaluate metabolic liver function.

The metabolic liver function test galactose elimination capacity requires a 6-hour fast, the infusion of galactose, blood sampling from the ear lobe, and collection of urine for 4 hours.

Other Name: Galactose elimination capacity

Procedure: Liver biopsy
Histological disease activity at time of diagnosis evaluating if any liver fibrosis

Procedure: Functional hepatic nitrogen clearance
Functional hepatic nitrogen clearance to evaluate metabolic liver function Functional hepatic nitrogen clearance requires a 12-hour fast, two venflons, the infusion of alanine, and urine sampling for 4 hours




Primary Outcome Measures :
  1. Measurement of the macrophage activation markers sCD163 [ Time Frame: Baseline, 1 year, 2 year, 3 year ]
    For the investigations a total of 100 ml of blood is drawn, all stored in a research biobank.

  2. Measurement of soluble mannose receptor (sMR) [ Time Frame: Baseline, 1 year, 2 year, 3 year ]
    For the investigations a total of 100 ml of blood is drawn, all stored in a research biobank.


Secondary Outcome Measures :
  1. Urinary copper excretion in 24 hour urine collection [ Time Frame: Baseline, 1 year, 2 year, 3 year ]
    The patient collects urine for 24 hours at home in a designated container, which is handed out at the department. The container is kept refrigerated and is brought to the control

  2. Ultrasound is performed for signs of liver cirrhosis. [ Time Frame: Baseline, 1 year, 2 year, 3 year ]
    Ultrasound is a non-invasive procedure. Signs og liver cirrhosis by ultrasound are surface modularity, a smaller liver, heterogeneous echo texture and signs of portal hypertension.

  3. Fibroscan is performed to evaluate liver stiffness (fibrosis) [ Time Frame: Baseline, 1 year, 2 year, 3 year ]
    Liver fibrosis will be determined using fibroscan, and reported as changes in the amount of fibrosis in the liver. The fibroscan is a non-invasive procedure.

  4. Continous Reaction Time to evaluate brain dysfunction [ Time Frame: Baseline, 1 year, 2 year, 3 year ]
    Continous Reaction Time is a computerized 10 minutes test that measures and combines motor reaction speed and sustained attention.

  5. Galactose elimination capacity is performed to evaluate metabolic liver function [ Time Frame: Baseline, 1 year, 2 year, 3 year ]
    The metabolic liver function test Galactose elimination capacity requires a 6-hour fast, the infusion of galactose, blood sampling from the ear lobe, and collection of urine for 4 hours.

  6. Histological disease activity at time of diagnosis and liver biopsy, evaluating if any liver fibrosis [ Time Frame: Baseline, 1 year, 2 year, 3 year ]
    Liver fibrosis will be also be determined on liver biopsies.

  7. Functional hepatic nitrogen clearance to evaluate metabolic liver function [ Time Frame: Baseline, 1 year, 2 year, 3 year ]
    Functional hepatic nitrogen clearancerequires a 12-hour fast, two venflons, the infusion of alanine, and urine sampling for 4 hours. It evaluates the metabolic liver function by measuring the clearance of alanine from blod by analyzing the amount og urea in the urine collected 4 hours after the start og the alanine infusion.

  8. The Portosystemic Encephalopathy to evaluate brain dysfunction [ Time Frame: Baseline, 1 year, 2 year, 3 year ]
    The Portosystemic Encephalopathy test is a 15-minute paper-pencil test battery comprised of 5 sub-tests: Digit Symbol test (DST), Number Connection Test A (NCT-A), Number Connection Test B (NCT-B), Serial Dotting Test (SDOT), and Line Tracing Test (LTT, time and errors).



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosed with Wilsons disease

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02702765


Contacts
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Contact: Jessica Björklund, Stud.med 004560748993 jebjoe@rm.dk
Contact: Henning Grønbæk, Professor 004578461546 Henngroe@rm.dk

Locations
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Denmark
Department of Hepatology and Gastroenterology, Aarhus University Hospital Recruiting
Aarhus, Denmark, 8000
Contact: Jessica Björklund, Research-year student    004560748993    jebjoe@rm.dk   
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Investigators
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Principal Investigator: Henning Grønbæk, Professor Aarhus University Hospital, Nørrebrogade 44, Aarhus C, Denmark, 8000

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02702765     History of Changes
Other Study ID Numbers: Wilson sCD163
First Posted: March 9, 2016    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: May 2018

Keywords provided by University of Aarhus:
sCD163
liver cirrhosis
disease severity

Additional relevant MeSH terms:
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Hepatolenticular Degeneration
Liver Diseases
Digestive System Diseases
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Metabolism, Inborn Errors
Metal Metabolism, Inborn Errors
Metabolic Diseases
Liver Extracts
Hematinics