Efficacy and Safety, Long-term Study of Zinc Acetate to Treat Wilson's Disease in Japan.
Information source: Nobelpharma
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Wilson's Disease
Intervention: NPC-02 (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Nobelpharma Official(s) and/or principal investigator(s): Koudou Ishii, M.D., Study Director, Affiliation: National MINAMIYOKOHAMA Hospital
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.
Clinical Details
Official title: Phase3, Open-Label, Clinical Trial of Zinc Acetate for Treatment of Wilson's Disease in Japan.
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Safety
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.
Eligibility
Minimum age: 1 Year.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Wilson's disease(adult, infant, pregnant woman)
Exclusion Criteria:
- Acute hepatitis
- Malignant tumor
Locations and Contacts
Additional Information
Starting date: March 2005
Last updated: April 10, 2014
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