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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: 19 February 2015
Main ID:  NCT00004339
Date of registration: 18/10/1999
Prospective Registration: No
Primary sponsor: National Center for Research Resources (NCRR)
Public title: Study of Tetrathiomolybdate in Patients With Wilson Disease
Scientific title:
Date of first enrolment: January 1994
Target sample size: 90
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00004339
Study type:  Interventional
Study design:  Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment  
Phase:  Phase 3
Countries of recruitment
United States
Contacts
Name:     George J. Brewer
Address: 
Telephone:
Email:
Affiliation:  University of Michigan
Key inclusion & exclusion criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

- Wilson disease presenting with neurologic or psychiatric symptoms

- No concurrent seizure activity

- No white matter lesions on brain magnetic resonance imaging

--Prior/Concurrent Therapy--

- No more than 2 weeks of prior therapy

- No penicillamine or trientine for longer than 2 weeks

--Patient Characteristics--

- Hepatic: No severe hepatic failure

- Other: No psychiatric or medical contraindication to protocol therapy

- Not pregnant



Age minimum: N/A
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Wilson Disease
Intervention(s)
Drug: tetrathiomolybdate
Drug: trientine
Primary Outcome(s)
Secondary Outcome(s)
Secondary ID(s)
NCRR-M01RR00042-1850
UMICH-FDU000505
UMMC-801
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
University of Michigan
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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