Status:
COMPLETED
Single Daily Dosage of Trientine for Maintenance Treatment for Wilson Disease
Lead Sponsor:
Yale University
Collaborating Sponsors:
Bausch Health Americas, Inc.
Conditions:
Wilson Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 saf...
Detailed Description
Wilson disease is a genetic disorder of copper metabolism inherited in an autosomal recessive fashion that afflicts \~1/30,000 individuals. Treatment for these individuals consists of medical therapy,...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01472874
Start Date
January 1 2010
End Date
July 1 2011
Last Update
April 15 2020
Active Locations (1)
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1
Yale University
New Haven, Connecticut, United States, 06520