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

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: September 13, 2005
Last updated: September 9, 2010
Last verified: September 2010
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • acute hepatitis
  • malignant tumor
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00212368

Sponsors and Collaborators
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 
Study First Received: September 13, 2005
Last Updated: September 9, 2010
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Hepatolenticular Degeneration
Basal Ganglia Diseases
Brain Diseases
Brain Diseases, Metabolic
Brain Diseases, Metabolic, Inborn
Central Nervous System Diseases
Digestive System Diseases
Genetic Diseases, Inborn
Heredodegenerative Disorders, Nervous System
Liver Diseases
Metabolic Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Metabolism, Inborn Errors
Metal Metabolism, Inborn Errors

ClinicalTrials.gov processed this record on May 26, 2016