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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT01472874
Date of registration: 11/11/2011
Prospective Registration: No
Primary sponsor: Yale University
Public title: Single Daily Dosage of Trientine for Maintenance Treatment for Wilson Disease
Scientific title: Single Daily Dosage of Trientine for Maintenance Treatment for Wilson Disease
Date of first enrolment: January 2010
Target sample size: 8
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01472874
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
United States
Contacts
Name:     Michael Schilsky, MD
Address: 
Telephone:
Email:
Affiliation:  Yale University
Key inclusion & exclusion criteria

Inclusion Criteria:

Established diagnosis of Wilson Disease:

- That have been treated for at least 1 year

- Compensated liver disease and/or stable neurological or psychiatric disease.

- Normal or minimal elevation of serum ALT (<2 times upper limit of normal)

- Non-ceruloplasmin copper <25 mcg/dl

Exclusion Criteria:

- Wilson disease diagnosis not well established Wilson disease treated for less than one
year Decompensated liver disease (ascites, jaundice, encephalopathy, bleeding due to
portal hypertension) Liver disease with elevations of ALT > 2 times upper limit of
normal A female who is pregnant or intends to become pregnant



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Wilson Disease
Intervention(s)
Drug: Once a day Trientine
Primary Outcome(s)
ALT [Time Frame: Months 1,2,3,6,9,12 (mean)]
ALT [Time Frame: Pre Treatment (mean)]
Cu Serum [Time Frame: Months 1,2,3,6,9,12 (mean)]
Cu Serum [Time Frame: Pre Treatment (mean)]
Secondary Outcome(s)
Albumin [Time Frame: Months 1,2,3,6,9,12 (mean)]
Albumin [Time Frame: Pre Treatment (mean)]
Cu Urine [Time Frame: Months 1,2,3,6,9,12 (mean)]
Cu Urine [Time Frame: Pre Treatment (mean)]
INR [Time Frame: Months 1,2,3,6,9,12 (mean)]
INR [Time Frame: Pre Treatment (mean)]
Zn Urine [Time Frame: Months 1,2,3,6,9,12 (mean)]
Zn Urine [Time Frame: Pre Treatment (mean)]
Secondary ID(s)
0902004694
ORPH-SYP-001
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Bausch Health Americas, Inc.
Ethics review
Results
Results available: Yes
Date Posted: 19/05/2014
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT01472874
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