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: April 10, 2014
Last verified: April 2014
  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: NPC-02
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:


Further study details as provided by Nobelpharma:

Primary Outcome Measures:
  • Safety [ Time Frame: During study period (up to 96W ) ] [ Designated as safety issue: Yes ]
    No of patients who have at least one adverse events.


Enrollment: 37
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
zinc acetate
Drug: NPC-02
zinc acetate

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.

  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
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: NCT00212355

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

Publications:
Responsible Party: Nobelpharma
ClinicalTrials.gov Identifier: NCT00212355     History of Changes
Other Study ID Numbers: NPC-02-2
Study First Received: September 13, 2005
Results First Received: April 9, 2014
Last Updated: April 10, 2014
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 August 21, 2014