Wilsons DiseaseNCT02702765
sCD163 and sMR in Wilsons Disease - Associations With Disease Severity and Fibrosis
A study testing Fibroscan, Ultrasound and Galactose in people with Wilsons Disease, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Wilsons Disease
- What is being tested?
- Fibroscan, Ultrasound and Galactose
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2016to Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed with Wilsons disease
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Hepatology and Gastroenterology, Aarhus University Hospital
Aarhus, 8000
About this study
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
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.
- Conditions
- Wilsons Disease
- Being tested
- Fibroscan, Ultrasound, Galactose, Liver biopsy, Functional hepatic nitrogen clearance
- Keywords
- sCD163, liver cirrhosis, disease severity
- Medical subject headings
- Hepatolenticular Degeneration, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FibroscanProcedure or surgery
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
UltrasoundProcedure or surgery
Ultrasound is a non-invasive procedure
GalactoseDrug
Also called Galactose elimination capacity
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 biopsyProcedure or surgery
Histological disease activity at time of diagnosis evaluating if any liver fibrosis
Functional hepatic nitrogen clearanceProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Wilsons disease | Experimental | All patients will receive all interventions (galactose elimination capacity test , ultrasound, fibroscan, continuous reaction time test and functional hepatic nitrogen clearance ), except liver biopsy. Receives: Procedure: Fibroscan; Procedure: Ultrasound; Drug: Galactose; Procedure: Liver biopsy; Procedure: Functional hepatic nitrogen clearance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the macrophage activation markers sCD163
For the investigations a total of 100 ml of blood is drawn, all stored in a research biobank.
Measured: Baseline, 1 year, 2 year, 3 year
Measurement of soluble mannose receptor (sMR)
For the investigations a total of 100 ml of blood is drawn, all stored in a research biobank.
Measured: Baseline, 1 year, 2 year, 3 year
Secondary outcomes (8)
Urinary copper excretion in 24 hour urine collection
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
Measured: Baseline, 1 year, 2 year, 3 year
Ultrasound is performed for signs of liver cirrhosis.
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.
Measured: Baseline, 1 year, 2 year, 3 year
Fibroscan is performed to evaluate liver stiffness (fibrosis)
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.
Measured: Baseline, 1 year, 2 year, 3 year
Continous Reaction Time to evaluate brain dysfunction
Continous Reaction Time is a computerized 10 minutes test that measures and combines motor reaction speed and sustained attention.
Measured: Baseline, 1 year, 2 year, 3 year
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.
Measured: Baseline, 1 year, 2 year, 3 year
Histological disease activity at time of diagnosis and liver biopsy, evaluating if any liver fibrosis
Liver fibrosis will be also be determined on liver biopsies.
Measured: Baseline, 1 year, 2 year, 3 year
Functional hepatic nitrogen clearance to evaluate metabolic liver function
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.
Measured: Baseline, 1 year, 2 year, 3 year
The Portosystemic Encephalopathy to evaluate brain dysfunction
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).
Measured: Baseline, 1 year, 2 year, 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionFeb 2020
- Study completionFeb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Wilsons DiseaseStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Henning Grønbæk, Professor, Principal investigator, Aarhus University Hospital, Nørrebrogade 44, Aarhus C, Denmark, 8000
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02702765
- Sponsor's protocol ID
- Wilson sCD163
- Status last verified
- Nov 2022
- First submitted
- 26 Feb 2016
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 30241550
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02702765
- Acronym / sponsor ID
- Wilson sCD163
- Conditions
- Wilsons Disease
- Keywords
- sCD163, liver cirrhosis, disease severity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- Feb 2016 (actual)
- Primary completion
- Feb 2020 (actual)
- Study completion
- Feb 2022 (actual)
- First posted
- 9 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wilsons disease | Experimental | Procedure: Fibroscan, Procedure: Ultrasound, Drug: Galactose, Procedure: Liver biopsy, Procedure: Functional hepatic nitrogen clearanceAll patients will receive all interventions (galactose elimination capacity test , ultrasound, fibroscan, continuous reaction time test and functional hepatic nitrogen clearance ), except liver biopsy. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosed with Wilsons disease
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FibroscanLiver 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 or surgery | Wilsons disease |
| UltrasoundUltrasound is a non-invasive procedure | Procedure or surgery | Wilsons disease |
| GalactoseAlso: Galactose elimination capacityGalactose 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. | Drug | Wilsons disease |
| Liver biopsyHistological disease activity at time of diagnosis evaluating if any liver fibrosis | Procedure or surgery | Wilsons disease |
| Functional hepatic nitrogen clearanceFunctional 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 | Procedure or surgery | Wilsons disease |
Primary outcome
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.
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.
8 secondary outcomes
Urinary copper excretion in 24 hour urine collection
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
Fibroscan is performed to evaluate liver stiffness (fibrosis)
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
Galactose elimination capacity is performed to evaluate metabolic liver function
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
Functional hepatic nitrogen clearance to evaluate metabolic liver function
Time frame: Baseline, 1 year, 2 year, 3 year
The Portosystemic Encephalopathy to evaluate brain dysfunction
Time frame: Baseline, 1 year, 2 year, 3 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Derived from this study: PubMed 30241550Bjorklund 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henning Grønbæk, Professor principal investigator
Aarhus University Hospital, Nørrebrogade 44, Aarhus C, Denmark, 8000
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fibroscan, Ultrasound and Galactose in people with Wilsons Disease, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of the macrophage activation markers sCD163 (time frame: Baseline, 1 year, 2 year, 3 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02702765, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022.