Off Treatment Urinary Copper Excretion in Wilson Disease, Pilot Study

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT07301216
Status
Recruiting
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Conditions

  • Wilson Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

This is a prospective study that will determine the optimal timing for 24-hour urinary copper excretion (UCE) measurement after temporary discontinuation of standard therapies in Wilson Disease (WD) patients. The primary objective is to assess whether off-treatment UCE (OT-UCE) correlates with non-ceruloplasmin-bound copper (NCC) levels, aiming to validate OT-UCE as a surrogate marker for systemic copper bioavailability and disease stability. Stable WD patients will be enrolled, temporarily taken off treatment under close monitoring, and undergo UCE and NCC testing. If OT-UCE is validated, it could serve as a practical biomarker for monitoring WD treatment and stability in clinical practice and future trials.

Key Dates

Start date
Jan 8, 2026
Status verified
Mar 2026
Primary completion
Jun 30, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
30 participants (estimated)

Arms

  • Arm: OT-UCE and NCC for Zinc treated WD patients
    OT-UCE and NCC will be measured in WD patients on Zinc therapy
  • Arm: OT-UCE and NCC for Trientine treated WD patients
    OT-UCE and NCC will be measured in WD patients on trientine therapy
  • Arm: OT-UCE and NCC for Penicillamine treated WD patients
    OT-UCE and NCC will be measured in WD patients on Penicillamine therapy

Primary Outcome Measure

Mean concentration of OT-UCE for each standard of care WD treatment [ Time Frame: days 1, 2, 3 and 4 post stopping WD meds ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Yale School of MedicineNew HavenConnecticut06520-

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By research site
Yale School of Medicine· New Haven, CT

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