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New blood test could help doctors better manage Wilson's disease

NCT ID NCT05783687

Knowledge-focused Sponsor: Orphalan Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at a new blood test that measures copper levels in people with Wilson's disease, a rare condition where copper builds up in the body. Researchers collected extra blood samples from 50 adults during routine visits over about a year. The goal was to see if this test can help doctors adjust treatment more accurately.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

50 people

The number who actually took part.

Started

Jun 2023

Finished

Sep 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adult patients (≥ 18 years old) with Wilson's Disease

Ages

18 years and older

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Willing and able to give informed consent for participation in the study 2. Male or female patients, aged 18 years or older as of signing the Informed Consent Form (ICF) 3. Able and willing to comply with study procedures and requirements, as judged by the treating physician 4. Established diagnosis of Wilson's Disease (Leipzig score \>4) 5. Either newly diagnosed or with elevated liver enzymes (defined as ALT, AST ≥1.5xULN) or 24-hour urinary copper excretion outside of recommended ranges \[chelation range 200-500mcg/24 hr; zinc \< 100mcg/24 hr\] 6. Adequate venous access to allow collection of blood samples Exclusion Criteria: 1. 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. 2. Patients with a New Wilson's Disease Index Score of \>7 3. In the opinion of the investigator, the patient is likely to be non-compliant or uncooperative for routine clinical visits during the study.

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Conditions

The condition(s) this trial relates to.

Wilson disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Wilson disease

Contacts and locations

Locations

  • Advent Health Orlando

    Orlando, Florida, 32803, United States

  • John Hopkins Hospital

    Baltimore, Maryland, 21287, United States

  • New York Presbyterian Hospital-Columbia University Medical Centre

    New York, New York, 10032, United States

  • Northwestern University Chicago (Hepatologist)

    Chicago, Illinois, 60611, United States

  • UC Davis Midtown Ambulatory Care Centre

    Sacramento, California, 95817, United States

  • University of Miami

    Miami, Florida, 33136, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • Vanderbilt University Medical Centre

    Nashville, Tennessee, 37212, United States

  • Yale University School of Medicine

    New Haven, Connecticut, 06520, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.