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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nobelpharma
ClinicalTrials.gov Identifier:
NCT00212355
First received: September 13, 2005
Last updated: October 16, 2012
Last verified: October 2012
History of Changes
  Purpose

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 Intervention Phase
Wilson's Disease
 Drug: Wilson's disease
 Phase 3

Study Type: Interventional
Study Design: 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:

MedlinePlus related topics: Wilson Disease
U.S. FDA Resources

Further study details as provided by Nobelpharma:

Primary Outcome Measures:
  • Safety [ Time Frame: During study period (up to 96W ) ] [ Designated as safety issue: Yes ]

Enrollment: 34
Study Start Date: March 2005
Study Completion Date: January 2009
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NPC-02 Drug: Wilson's disease

  Eligibility

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

Inclusion Criteria:

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

Exclusion Criteria:

  • acute hepatitis
  • malignant tumor
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00212355

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

No publications provided

Responsible Party: Nobelpharma
ClinicalTrials.gov Identifier: NCT00212355     History of Changes
Other Study ID Numbers: NPC-02-2
Study First Received: September 13, 2005
Last Updated: October 16, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

ClinicalTrials.gov processed this record on June 17, 2013