Wilson Disease Trial, Recruiting NCT07301216 Sponsor: Yale University Condition: Wilson Disease
Back to Wilson Disease

Wilson Disease Trial, Recruiting

NCT07301216
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been diagnosed with Wilson Disease, confirmed by a scoring system called the Leipzig score (score of 4 or higher)
  • You are willing and able to sign a consent form agreeing to take part in the study
  • You are willing to follow all study requirements, including collecting urine samples over 24-hour periods and attending follow-up visits for the full length of the study
  • You have been receiving treatment for Wilson Disease for at least 12 months before joining the study
  • Your liver enzyme levels (ASAT and ALAT) are not more than twice the normal upper limit
  • Your blood clotting level (INR) is below 1.5, or has been stable for at least 6 months if it was previously elevated, and you are not on blood-thinning medication
  • Your kidneys are working at a sufficient level (eGFR above 30 cc/min)
  • Your Wilson Disease treatment has not changed in the 6 months before joining the study

Who may not be able to join:

  • You are currently taking two Wilson Disease treatments at the same time (for example, zinc combined with d-penicillamine or trientine)
  • You are currently pregnant or breastfeeding
  • You have used estrogen-based treatment (such as certain contraceptives or hormone therapies) within the last month
  • You have liver cirrhosis and have had a serious liver-related complication in the last 6 months, such as fluid build-up in the abdomen, a serious infection, bleeding from the food pipe, or episodes of confusion related to liver problems
  • The trial team believes you may not be able to complete the required urine collections or attend follow-up visits as needed
  • You have previously not followed your treatment plan or low-copper diet in a way that could affect the reliability of the study results
  • You are of childbearing age and test positive on a urine pregnancy test taken before the start of the study (confirm with trial site for full details on testing requirements)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Michael L Schilsky, MD FAASLD, Yale University

Phone: 203 737 2702

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Registry
ClinicalTrials.gov
Start date
8 January 2026
Est. completion
30 June 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Mean concentration of OT-UCE for each standard of care WD treatment; Mean NCC concentration for each WD treatment

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov