Back to resultsEfficacy and Safety Study of Zinc Acetate to Treat Wilson's Disease in Japan.
Primary Purpose
Wison's Disease
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Zinc acetate
Sponsored by
About this trial
This is an interventional treatment trial for Wison's Disease
Eligibility Criteria
Inclusion Criteria: Wilson's disease(adult,infant,pregnant woman) Exclusion Criteria: acute hepatitis malignant tumor
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00212368
Brief Title
Efficacy and Safety Study of Zinc Acetate to Treat Wilson's Disease in Japan.
Official Title
Phase3,Open-label,Clinical Trial of Zinc Acetate for Treatment of Wilson's Disease in Japan.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
December 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Nobelpharma
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wison's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Zinc acetate
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Wilson's disease(adult,infant,pregnant woman)
Exclusion Criteria:
acute hepatitis
malignant tumor
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Koudou Ishii, M.D.
Organizational Affiliation
National MINAMIYOKOHAMA Hospital
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety Study of Zinc Acetate to Treat Wilson's Disease in Japan.
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