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

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ClinicalTrials.gov Identifier: NCT00212355
Recruitment Status : Completed
First Posted : September 21, 2005
Results First Posted : May 14, 2014
Last Update Posted : May 14, 2014
Sponsor:
Information provided by (Responsible Party):
Nobelpharma

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
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 [ Time Frame: During study period (up to 96W ) ]
    No of patients who have at least one adverse events.



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

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 ClinicalTrials.gov identifier (NCT number): NCT00212355


Sponsors and Collaborators
Nobelpharma
Investigators
Study Director: Koudou Ishii, M.D. National MINAMIYOKOHAMA Hospital

Publications of Results:
Responsible Party: Nobelpharma
ClinicalTrials.gov Identifier: NCT00212355     History of Changes
Other Study ID Numbers: NPC-02-2
First Posted: September 21, 2005    Key Record Dates
Results First Posted: May 14, 2014
Last Update Posted: May 14, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
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