Single Daily Dosage of Trientine for Maintenance Treatment for Wilson Disease

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT01472874
Status
Completed

Conditions

  • Wilson Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Once a day Trientine — DRUG
    Trientine at a dosage of \~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year.

Study Details

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).

Key Dates

First listed
Nov 17, 2011
Start date
Jan 31, 2010
Status verified
Apr 2020
Primary completion
Jul 31, 2011
Completion
Jul 31, 2011

Study Design

Enrollment
8 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Once a day Trientine
    Patients receive once a day trientine

Primary Outcome Measure

ALT [ Time Frame: Pre Treatment (mean) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Yale UniversityNew HavenConnecticut06520-

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By research site
Yale University· New Haven, CT

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