Efficacy and Safety, Long-term Study of Zinc Acetate to Treat Wilson's Disease in Japan.
The purpose of this long-term study is to determine whether Zinc Acetate is effective and safe in the treatment of Wilson's disease among Japanese.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase3, Open-Label, Clinical Trial of Zinc Acetate for Treatment of Wilson's Disease in Japan.|
- Safety [ Time Frame: During study period (up to 96W ) ] [ Designated as safety issue: Yes ]No of patients who have at least one adverse events.
|Study Start Date:||March 2005|
|Study Completion Date:||January 2009|
|Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
Wilson disease is an autosomal recessive disorder with copper metabolism. In Japan, the standard treatment is the use of copper chelating agents, such as D-penicillamine and trientine. In this study, we investigate efficacy on zinc acetate in Japanese patients with Wilson disease.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00212355
|Study Director:||Koudou Ishii, M.D.||National MINAMIYOKOHAMA Hospital|