Back to resultsEfficacy and Safety, Long-term Study of Zinc Acetate to Treat Wilson's Disease in Japan.
Primary Purpose
Wilson's Disease
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
NPC-02
Sponsored by
About this trial
This is an interventional treatment trial for Wilson's Disease
Eligibility Criteria
Inclusion Criteria: Wilson's disease(adult, infant, pregnant woman) Exclusion Criteria: Acute hepatitis Malignant tumor
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
NPC-02
Arm Description
zinc acetate
Outcomes
Primary Outcome Measures
Safety and Efficacy
Number of patients who have at least one adverse events. ALT Change
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00212355
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.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nobelpharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wilson's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NPC-02
Arm Type
Experimental
Arm Description
zinc acetate
Intervention Type
Drug
Intervention Name(s)
NPC-02
Intervention Description
zinc acetate
Primary Outcome Measure Information:
Title
Safety and Efficacy
Description
Number of patients who have at least one adverse events. ALT Change
Time Frame
During study period (up to 96W )
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
Citations:
PubMed Identifier
21078496
Citation
Shimizu N, Fujiwara J, Ohnishi S, Sato M, Kodama H, Kohsaka T, Inui A, Fujisawa T, Tamai H, Ida S, Itoh S, Ito M, Horiike N, Harada M, Yoshino M, Aoki T. Effects of long-term zinc treatment in Japanese patients with Wilson disease: efficacy, stability, and copper metabolism. Transl Res. 2010 Dec;156(6):350-7. doi: 10.1016/j.trsl.2010.08.007. Epub 2010 Sep 23.
Results Reference
result
Learn more about this trial
Efficacy and Safety, Long-term Study of Zinc Acetate to Treat Wilson's Disease in Japan.
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