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Efficacy and Safety, Long-term Study of Zinc Acetate to Treat Wilson's Disease in Japan.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00212355
Recruitment Status : Completed
First Posted : September 21, 2005
Results First Posted : May 14, 2014
Last Update Posted : April 24, 2019
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Wilson's Disease Drug: NPC-02 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase3, Open-Label, Clinical Trial of Zinc Acetate for Treatment of Wilson's Disease in Japan.
Study Start Date : March 2005
Actual Primary Completion Date : April 2008
Actual Study Completion Date : January 2009

Arm Intervention/treatment
Experimental: NPC-02
zinc acetate
Drug: NPC-02
zinc acetate

Primary Outcome Measures :
  1. Safety and Efficacy [ Time Frame: During study period (up to 96W ) ]
    Number of patients who have at least one adverse events. ALT Change

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Wilson's disease(adult, infant, pregnant woman)

Exclusion Criteria:

  • Acute hepatitis
  • Malignant tumor

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00212355

Sponsors and Collaborators
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Study Director: Koudou Ishii, M.D. National MINAMIYOKOHAMA Hospital
Publications of Results:
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Responsible Party: Nobelpharma Identifier: NCT00212355    
Other Study ID Numbers: NPC-02-2
First Posted: September 21, 2005    Key Record Dates
Results First Posted: May 14, 2014
Last Update Posted: April 24, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Hepatolenticular Degeneration
Liver Diseases
Digestive System Diseases
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Metabolism, Inborn Errors
Metal Metabolism, Inborn Errors
Metabolic Diseases