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Real World Evidence Study in Subjects With Wilson's Disease

NCT05783687 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2026-04-06

No results posted yet for this study

Summary

This non-interventional Real-World Evidence (RWE) study aims to describe non-ceruloplasmin copper values obtained using a new NCC Speciation assay by taking a small (up to 10mLs) volume of additional blood from patients with Wilson's Disease, around the time when routine blood sampling is expected to be scheduled by the treating physician. Data will be collected over an approximate 12-month period.

Conditions

  • Wilson Disease

Interventions

DIAGNOSTIC_TEST

NCC-Sp Assay

Orphalan has developed a new NCC speciation assay (NCC-Sp) using liquid chromatography inductively coupled plasma mass spectroscopy (LC-ICP-MS) to measure serum copper and ceruloplasmin bound copper from which non ceruloplasmin bound copper (NCC) is estimated.

Sponsors & Collaborators

  • Orphalan

    lead INDUSTRY

Principal Investigators

  • Mike Schilsky · Yale University School of Medicine, New Haven, Connecticut

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-28
Primary Completion
2025-09-12
Completion
2025-09-12

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05783687 on ClinicalTrials.gov