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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00212368
First Posted: September 21, 2005
Last Update Posted: September 10, 2010
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.
Information provided by:
Nobelpharma
  Purpose
The purpose of this study is to determine whether Zinc Acetate is effective and safe in the treatment of Wilson's disease among Japanese.

Condition Intervention Phase
Wison's Disease Drug: Zinc acetate Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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.

Resource links provided by NLM:


Further study details as provided by Nobelpharma:

Study Start Date: October 2004
Study Completion Date: December 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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): NCT00212368


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

ClinicalTrials.gov Identifier: NCT00212368     History of Changes
Other Study ID Numbers: NPC-02-1
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: September 10, 2010
Last Verified: September 2010

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
Zinc
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs