Brief Title
Efficacy and Safety, Long-term 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.
Brief Summary
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.
Detailed Description
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Safety and Efficacy
Condition
Wilson's Disease
Intervention
NPC-02
Study Arms / Comparison Groups
NPC-02
Description: zinc acetate
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
37
Start Date
March 2005
Completion Date
January 2009
Primary Completion Date
April 2008
Eligibility Criteria
Inclusion Criteria:
- Wilson's disease(adult, infant, pregnant woman)
Exclusion Criteria:
- Acute hepatitis
- Malignant tumor
Gender
All
Ages
1 Year - N/A
Accepts Healthy Volunteers
No
Contacts
Koudou Ishii, M.D., ,
Administrative Informations
NCT ID
NCT00212355
Organization ID
NPC-02-2
Responsible Party
Sponsor
Study Sponsor
Nobelpharma
Study Sponsor
Koudou Ishii, M.D., Study Director, National MINAMIYOKOHAMA Hospital
Verification Date
April 2019