Condition: Wilson Disease · Sponsor: Yale University
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.
This description comes directly from the study's public registry record.
Sefa Keserci, MD · 203 737 2702 · sefa.keserci@yale.edu
Hatice Maras, MD · hatice.maras@yale.edu
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| Yale School of Medicine | New Haven, Connecticut, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07301216