Off Treatment Urinary Copper Excretion in Wilson Disease, Pilot Study
NCT ID: NCT07301216
Last Updated: 2025-12-24
Study Results
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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RECRUITING
30 participants
OBSERVATIONAL
2026-02-28
2027-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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OT-UCE and NCC for Zinc treated WD patients
OT-UCE and NCC will be measured in WD patients on Zinc therapy
No interventions assigned to this group
OT-UCE and NCC for Trientine treated WD patients
OT-UCE and NCC will be measured in WD patients on trientine therapy
No interventions assigned to this group
OT-UCE and NCC for Penicillamine treated WD patients
OT-UCE and NCC will be measured in WD patients on Penicillamine therapy
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Provision of signed and dated informed consent form.
* Stated willingness to comply with all study procedures (serial 24 h urine collections and local collection of samples for NCC, liver function and estimated GFR) and availability for the duration of the study.
* Treated WD for at least 12 months prior to study entry.
* Aminotransferase values (ASAT and ALAT) \< 2 times the upper limit of normal (ULN).
* INR \< 1.5 or stable INR for those with initial elevated INR for at least six months prior to study entry in the absence of anticoagulation therapy.
* Renal function defined as eGFR \> 30 cc/min.
* No change of WD therapy during the previous 6 months of study enrollment.
Exclusion Criteria
* Current Pregnancy or lactation. \*
* Recent estrogen-based treatment (in the last month).
* Cirrhosis with recent hepatic decompensation (within the last 6 months) - new onset of ascites, spontaneous bacterial peritonitis, esophageal variceal bleeding, or hepatic encephalopathy
* Investigator believes the patient will be unable to do the required 24-hour urine studies and participate in the follow up visits as expected.
* Previous non-compliance for therapy and/or to low-copper diet that would compromise the evaluation of previous UCE and/ or results from the off-treatment period.
* Childbearing aged patients recruited outside of the registry will be reviewed, and the patients will be asked to perform an initial urine pregnancy test prior to the recommended blood testing (approximately 60 to 90 days prior to intervention). They will be permitted to continue with the screening process if the result is negative. They will be asked to perform a second urine pregnancy test as close as possible prior to study intervention (discontinuation of treatment). If the result of the second pregnancy test is negative they will be permitted to continue with the protocol, but if the result is positive they will be excluded from further participation at that time.
18 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Yale University
OTHER
Responsible Party
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Principal Investigators
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Michael L Schilsky, MD FAASLD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Yale School of Medicine
New Haven, Connecticut, United States
Countries
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Central Contacts
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References
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Solovyev N, Ala A, Schilsky M, Mills C, Willis K, Harrington CF. Biomedical copper speciation in relation to Wilson's disease using strong anion exchange chromatography coupled to triple quadrupole inductively coupled plasma mass spectrometry. Anal Chim Acta. 2020 Feb 15;1098:27-36. doi: 10.1016/j.aca.2019.11.033. Epub 2019 Nov 15.
Harrington CF, Carpenter G, Coverdale JPC, Douglas L, Mills C, Willis K, Schilsky ML. Accurate non-ceruloplasmin bound copper: a new biomarker for the assessment and monitoring of Wilson disease patients using HPLC coupled to ICP-MS/MS. Clin Chem Lab Med. 2024 Jul 30. doi: 10.1515/cclm-2024-0213. Online ahead of print.
Other Identifiers
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2000040776
Identifier Type: -
Identifier Source: org_study_id