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Sponsors and Collaborators: |
National Center for Research Resources (NCRR) University of Michigan |
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Information provided by: | National Center for Research Resources (NCRR) |
ClinicalTrials.gov Identifier: | NCT00004338 |
OBJECTIVES: I. Establish the safety and efficacy of extended maintenance zinc therapy in 200 patients with Wilson disease.
II. Establish further the role of zinc in the prophylactic treatment of presymptomatic patients by increasing the current cohort from 80 to at least 100 patients. III. Establish further the role of zinc therapy in pregnant patients with Wilson disease.
IV. Establish further the role of zinc therapy in children with Wilson disease.
Condition | Intervention | Phase |
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Wilson Disease |
Drug: zinc acetate |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Safety/Efficacy Study |
Estimated Enrollment: | 300 |
Study Start Date: | October 1993 |
PROTOCOL OUTLINE:
Patients receive copper regulation therapy with zinc acetate: an existing cohort on maintenance therapy will be followed for long-term data collection; presymptomatic patients are treated prophylactically; and pregnant patients are evaluated for fetal outcome. All patients are evaluated for copper balance, clinical control, and toxicity.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA: Wilson disease Presymptomatic, pregnant, and children 16 years or younger patients eligible Patient age: Any age, including children
United States, Michigan | |
University of Michigan Health Systems | |
Ann Arbor, Michigan, United States, 48109 |
Study Chair: | George J. Brewer | University of Michigan |
Study ID Numbers: | 199/11897, UMMC-310 |
Study First Received: | October 18, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00004338 History of Changes |
Health Authority: | United States: Federal Government |
Wilson disease inborn errors of metabolism rare disease |
Liver Diseases Metabolic Diseases Ganglion Cysts Hepatolenticular Degeneration Basal Ganglia Diseases Rare Diseases Central Nervous System Diseases Neurodegenerative Diseases Brain Diseases Metabolism, Inborn Errors |
Digestive System Diseases Heredodegenerative Disorders, Nervous System Genetic Diseases, Inborn Wilson Disease Movement Disorders Zinc Brain Diseases, Metabolic, Inborn Metabolic Disorder Brain Diseases, Metabolic |
Liver Diseases Metabolic Diseases Hepatolenticular Degeneration Basal Ganglia Diseases Nervous System Diseases Central Nervous System Diseases Brain Diseases Neurodegenerative Diseases |
Metal Metabolism, Inborn Errors Metabolism, Inborn Errors Digestive System Diseases Heredodegenerative Disorders, Nervous System Genetic Diseases, Inborn Movement Disorders Brain Diseases, Metabolic, Inborn Brain Diseases, Metabolic |