Real World Evidence Study in Subjects With Wilson's Disease

Completed

Conditions studied: Wilson Disease

In brief

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.

Key facts

Study ID

NCT05783687

Run by

Orphalan

People needed

50

Starts

2023-06-28

Expected to finish

2025-09-12

Last updated by the study team

2026-04-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Willing and able to give informed consent for participation in the study
• Male or female patients, aged 18 years or older as of signing the Informed Consent Form (ICF)
• Able and willing to comply with study procedures and requirements, as judged by the treating physician
• Established diagnosis of Wilson's Disease (Leipzig score >4)
• Either newly diagnosed or with elevated liver enzymes (defined as ALT, AST ≥1.5xULN) or 24-hour urinary copper excretion outside of recommended ranges [chelation range 200-500mcg/24 hr; zinc < 100mcg/24 hr]
• Adequate venous access to allow collection of blood samples

You may not qualify if…

• Major systemic disease or other illness that would, in the opinion of the investigator, compromise patient safety or interfere with the collection or interpretation of the study results.
• Patients with a New Wilson's Disease Index Score of >7
• In the opinion of the investigator, the patient is likely to be non-compliant or uncooperative for routine clinical visits during the study.

Where it is running

• UC Davis Midtown Ambulatory Care Centre — Sacramento, California, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• University of Miami — Miami, Florida, United States
• Advent Health Orlando — Orlando, Florida, United States
• Northwestern University Chicago (Hepatologist) — Chicago, Illinois, United States
• John Hopkins Hospital — Baltimore, Maryland, United States
• University of Michigan — Ann Arbor, Michigan, United States
• New York Presbyterian Hospital-Columbia University Medical Centre — New York, New York, United States
• Vanderbilt University Medical Centre — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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