Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT07301216 · ClinicalTrials.gov registry record

Off Treatment Urinary Copper Excretion in Wilson Disease, Pilot Study

A clinical trial of Wilson Disease, sponsored by Yale University.

Recruiting
Registry status
30
Enrollment target
1
Study location

NCT07301216: Recruiting study of Wilson Disease, sponsored by Yale University.

NCT07301216 is a study of Wilson Disease that is actively recruiting participants, run by Yale University. The registered enrollment target is 30 participants, below the 119-participant average among 4 other Wilson Disease trials with a reported enrollment target (75% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT07301216, a study of Wilson Disease, is actively recruiting participants, sponsored by Yale University.

RECRUITING
Registry status
30 participants
Enrollment target
1
Study location

Study Summary

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.

Primary Outcome

Urine samples will be collected daily for 4 days after stopping WD medications. The sequential evaluation of OT-UCE over a maximum of 4 days after treatment withdrawal will allow investigators to define the optimal ranges for UCE and select the best time-point for OT-UCE evaluations for WD patients on the 3 different therapies.

Conditions Studied

Wilson Disease

Study Locations (1)

Connecticut

  • Yale School of Medicine - New Haven

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2026-01-08
Est. Completion 2028-09-30
Yale University

1,492 total trials

What NCT07301216 shows while recruiting

NCT07301216 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 119-participant average among 4 other Wilson Disease trials with a reported enrollment target (75% lower).

The record links to 1 condition, with Wilson Disease appearing as the primary indexed condition, and to 0 interventions.

NCT07301216 reports a single indexed study location in Connecticut.

Frequently Asked Questions

What is clinical trial NCT07301216 about?

NCT07301216 is a clinical study titled "Off Treatment Urinary Copper Excretion in Wilson Disease, Pilot Study". 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-c...

What is the current status of trial NCT07301216?

This trial is currently recruiting. The enrollment target is 30 participants. The study started on 2026-01-08. Estimated completion is 2028-09-30.

What conditions does trial NCT07301216 study?

This clinical trial studies the following conditions: Wilson Disease.

Who is sponsoring clinical trial NCT07301216?

This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07301216 being conducted?

This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Wilson Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT00977977 · 30 participants · Phase 2

    Rituximab Plus Cyclosporine in Idiopathic Membranous Nephropathy

  • NCT01459107 · 30 participants · Phase 2

    Human Upper Extremity Allotransplantation

  • NCT01666080 · 30 participants · NA

    Second or Greater Allogeneic Hematopoietic Stem Cell Transplant Using Reduced Intensity Conditioning (RIC)

  • NCT01720836 · 30 participants · Phase 1

    Study of the Immune Response of MUC1 (Mucin1) Peptide Vaccine for Non-small Cell Lung Cancer

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

More recruiting context for NCT07301216

Source: ClinicalTrials.gov NCT07301216, the US trial registry maintained by the National Library of Medicine. NCT07301216 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.