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The Assessment of Copper Parameters in Wilson Disease Participants on Standard of Care Treatment

NCT02763215 · View on ClinicalTrials.gov ↗

Study Summary

This was a 24-month study to assess copper parameters in participants with Wilson disease (WD) treated with standard of care (SoC) medications. After providing informed consent, participants meeting all inclusion and no exclusion criteria were enrolled into the study as outpatients. The participants' routine clinic visits were scheduled according to the standard clinical practice at the study center and at the discretion of the treating physician at approximate 6-month intervals. At the time of enrollment, participants were receiving SoC medications for the treatment of WD, which could include penicillamine, trientine, zinc, or a combination of a copper chelator and zinc. If treatment was interrupted or stopped during the course of the study, participants continued in the study and biological samples and clinical data were continued to be collected for the full 24-month study period. Dosing with SoC agents was individualized and managed by the treating physician at the study center according to standard clinical practice at the site.

Conditions Studied

Interventions

  • DRUG Standard of Care Medications

Study Locations (10)

Other

  • Clinical Trial Site — Vienna
  • Clinical Trial Site — Heidelberg
  • Clinical Trial Site — Warsaw
  • Clinical Trial Site — Birmingham
  • Clinical Trial Site — Guildford

Connecticut

  • Clinical Trial Site — New Haven

Illinois

  • Clinical Trial Site — Chicago

Michigan

  • Clinical Trial Site — Ann Arbor

Tennessee

  • Clinical Trial Site — Nashville

Washington

  • Clinical Trial Site — Seattle

Trial Details

FieldValue
Enrollment Target 64 participants
Start Date 2016-05-19
Est. Completion 2019-01-21

Sponsor

Alexion Pharmaceuticals

109 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02763215

The ClinicalTrials.gov registry entry for NCT02763215 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alexion Pharmaceuticals, which has 109 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Wilson Disease appearing as the primary indexed condition, and to 1 intervention — of which Standard of Care Medications is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02763215 reports 10 study locations spanning 6 distinct geographic areas — top geographies include Other, Connecticut, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02763215 about?

NCT02763215 is a clinical study titled "The Assessment of Copper Parameters in Wilson Disease Participants on Standard of Care Treatment". This was a 24-month study to assess copper parameters in participants with Wilson disease (WD) treated with standard of care (SoC) medications. After providing informed consent, participants meeting all inclusion and no exclusion criteria were enrolled into the study as outpatients. The participant...

What is the current status of trial NCT02763215?

This trial is currently completed. The enrollment target is 64 participants. The study started on 2016-05-19. Estimated completion is 2019-01-21.

What conditions does trial NCT02763215 study?

This clinical trial studies the following conditions: Wilson Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02763215?

The interventions under investigation include: Standard of Care Medications (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02763215?

This trial is sponsored by Alexion Pharmaceuticals, which has 109 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02763215 being conducted?

This trial has 10 study locations across Connecticut, Illinois, Michigan, Tennessee, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial