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NCT01472874 · ClinicalTrials.gov registry record · NA
Single Daily Dosage of Trientine for Maintenance Treatment for Wilson Disease
A NA study, sponsored by Yale University.
- Completed
- Registry status
- NA
- Development phase
- 8
- Enrollment target
NCT01472874 is a NA study that has completed, run by Yale University. The registered enrollment target is 8 participants.
The verdict
NCT01472874, a NA study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- NA
- Development phase
- 8 participants
- Enrollment target
Study Summary
Hypothesis: The investigators postulate that patients with Wilson disease who are asymptomatic or who have been effectively treated for their symptoms and are in a maintenance phase therapy can be safely and effectively treated with a single daily dosage of the chelating agent trientine. Specific Aims: To demonstrate that a single daily treatment with trientine is as effective or better than a patient's current maintenance therapy. This will be accomplished by performance of a case control prospective study of patients on their prior therapy, and during a period of treatment with a single weight based dose regimen of trientine. The primary endpoint for this study is the demonstration of equivalence to a patient's prior therapy. Secondary endpoints include: 1) demonstration of stability or improvement in parameters of copper metabolism; 2) improvement in adherence to therapy; 3) no progression of liver disease (defined by changes in synthetic function, albumin and INR, and fibrosis by Fibrotest).
Interventions
- DRUG Once a day Trientine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2010-01 |
| Est. Completion | 2011-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01472874
The ClinicalTrials.gov registry entry for NCT01472874 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Once a day Trientine is the first listed.
NCT01472874 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01472874 about?
NCT01472874 is a clinical study titled "Single Daily Dosage of Trientine for Maintenance Treatment for Wilson Disease". Hypothesis: The investigators postulate that patients with Wilson disease who are asymptomatic or who have been effectively treated for their symptoms and are in a maintenance phase therapy can be safely and effectively treated with a single daily dosage of the chelating agent trientine. Specific A...
What is the current status of trial NCT01472874?
This trial is currently completed. It is a NA study. The enrollment target is 8 participants. The study started on 2010-01. Estimated completion is 2011-07.
What interventions are being tested in trial NCT01472874?
The interventions under investigation include: Once a day Trientine (DRUG).
Who is sponsoring clinical trial NCT01472874?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
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