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Efficacy and Safety Study of Zinc Acetate to Treat Wilson's Disease in Japan.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00212368
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : September 10, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to determine whether Zinc Acetate is effective and safe in the treatment of Wilson's disease among Japanese.

Condition or disease Intervention/treatment Phase
Wison's Disease Drug: Zinc acetate Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase3,Open-label,Clinical Trial of Zinc Acetate for Treatment of Wilson's Disease in Japan.
Study Start Date : October 2004
Primary Completion Date : August 2005
Study Completion Date : December 2005


Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Wilson's disease(adult,infant,pregnant woman)

Exclusion Criteria:

  • acute hepatitis
  • malignant tumor
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00212368


Sponsors and Collaborators
Nobelpharma
Investigators
Study Director: Koudou Ishii, M.D. National MINAMIYOKOHAMA Hospital
More Information

ClinicalTrials.gov Identifier: NCT00212368     History of Changes
Other Study ID Numbers: NPC-02-1
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: September 10, 2010
Last Verified: September 2010

Additional relevant MeSH terms:
Hepatolenticular Degeneration
Liver Diseases
Digestive System Diseases
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Metabolic Diseases
Metabolism, Inborn Errors
Metal Metabolism, Inborn Errors
Zinc
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs