New Haven, CTNCT07301216Now EnrollingIRB Ready

Wilson Disease Clinical Trial in New Haven, CT

Access cutting-edge wilson disease treatment through this clinical trial at a research site in New Haven. Study-provided care at no cost to qualified participants.

Sponsored by Yale University

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IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related wilson disease treatment provided free

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Why Participate?

  • No-Cost Study Care

  • Local to New Haven

    Convenient for CT residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit New Haven site if eligible
  4. 4Begin participation

About This Wilson Disease Study in New Haven

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.

Sponsor: Yale University

Who Can Participate

Inclusion Criteria

Patients with Wilson Disease as defined by Leipzig score ≥4.
Provision of signed and dated informed consent form.
Stated willingness to comply with all study procedures (serial 24 h urine collections and local collection of samples for NCC, liver function and estimated GFR) and availability for the duration of the study.
Treated WD for at least 12 months prior to study entry.
Aminotransferase values (ASAT and ALAT) \< 2 times the upper limit of normal (ULN).
INR \< 1.5 or stable INR for those with initial elevated INR for at least six months prior to study entry in the absence of anticoagulation therapy.
Renal function defined as eGFR \> 30 cc/min.
No change of WD therapy during the previous 6 months of study enrollment.

Exclusion Criteria

Current dual / mixed therapy for WD (i.e. zinc and d-penicillamine or trientine at the same time)
Current Pregnancy or lactation. \
Recent estrogen-based treatment (in the last month).
Cirrhosis with recent hepatic decompensation (within the last 6 months) - new onset of ascites, spontaneous bacterial peritonitis, esophageal variceal bleeding, or hepatic encephalopathy
Investigator believes the patient will be unable to do the required 24-hour urine studies and participate in the follow up visits as expected.
Previous non-compliance for therapy and/or to low-copper diet that would compromise the evaluation of previous UCE and/ or results from the off-treatment period.
Childbearing aged patients recruited outside of the registry will be reviewed, and the patients will be asked to perform an initial urine pregnancy test prior to the recommended blood testing (approximately 60 to 90 days prior to intervention). They will be permitted to continue with the screening process if the result is negative. They will be asked to perform a second urine pregnancy test as close as possible prior to study intervention (discontinuation of treatment). If the result of the second pregnancy test is negative they will be permitted to continue with the protocol, but if the result is positive they will be excluded from further participation at that time. Childbearing aged patients recruited from the registry who meet inclusion criteria and may move directly to the study intervention will be required to perform a urine pregnancy test as close as possible to the time prior to the initiation of the study protocol (discontinuation of treatment).

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in New Haven?

Yes, this clinical trial (NCT07301216) has an active research site in New Haven, CT that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Wilson Disease Treatment Options in New Haven, CT

If you're searching for wilson disease treatment options in New Haven, CT, this clinical trial (NCT07301216) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our New Haven research site is actively enrolling participants for this clinical trial. You'll receive care from experienced wilson disease specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all wilson disease clinical trials near you to find additional studies recruiting in your area.

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