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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


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.


Minimum age: 1 Year. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 20, 2015

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