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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: Completed NA study, sponsored by Yale University.
NCT01472874 is a NA study that has completed, run by Yale University. The registered enrollment target is 8 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Alanine transaminase
Interventions
- DRUG Once a day Trientine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2010-01 |
| Est. Completion | 2011-07 |
| Phase | NA |
What the finished NCT01472874 record still lists
NCT01472874 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Once a day Trientine is the first listed.
NCT01472874 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01472874's enrollment target sits among peer trials
8 1976th of 2000 higher than 19 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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