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

NCT ID: NCT02702765

Last Updated: 2022-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2022-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Wilsons Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Fibroscan

Intervention Type PROCEDURE

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

Ultrasound

Intervention Type PROCEDURE

Ultrasound is a non-invasive procedure

Galactose

Intervention Type DRUG

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.

Liver biopsy

Intervention Type PROCEDURE

Histological disease activity at time of diagnosis evaluating if any liver fibrosis

Functional hepatic nitrogen clearance

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Ultrasound

Ultrasound is a non-invasive procedure

Intervention Type PROCEDURE

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.

Intervention Type DRUG

Liver biopsy

Histological disease activity at time of diagnosis evaluating if any liver fibrosis

Intervention Type 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

Intervention Type PROCEDURE

Other Intervention Names

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Galactose elimination capacity

Eligibility Criteria

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Inclusion Criteria

* diagnosed with Wilsons disease

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Henning Grønbæk, Professor

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital, Nørrebrogade 44, Aarhus C, Denmark, 8000

Locations

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Department of Hepatology and Gastroenterology, Aarhus University Hospital

Aarhus, , Denmark

Site Status

Countries

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Denmark

References

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Bjorklund J, Laursen TL, Sandahl TD, Moller HJ, Vilstrup H, Ott P, Gronbaek H. High hepatic macrophage activation and low liver function in stable Wilson patients - a Danish cross-sectional study. Orphanet J Rare Dis. 2018 Sep 21;13(1):169. doi: 10.1186/s13023-018-0910-7.

Reference Type DERIVED
PMID: 30241550 (View on PubMed)

Other Identifiers

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Wilson sCD163

Identifier Type: -

Identifier Source: org_study_id

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