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

Brief Title

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

Official Title

Phase3, Open-Label, Clinical Trial of Zinc Acetate for Treatment of Wilson's Disease in Japan.

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.
    

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 Phase

Phase 3

Study Type

Interventional

Primary Outcome

Safety and Efficacy

Condition

Wilson's Disease

Intervention

NPC-02

Study Arms / Comparison Groups

 NPC-02

Description:  zinc acetate

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

37

Start Date

March 2005

Completion Date

January 2009

Primary Completion Date

April 2008

Eligibility Criteria

        Inclusion Criteria:

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

        Exclusion Criteria:

          -  Acute hepatitis

          -  Malignant tumor
      

Gender

All

Ages

1 Year - N/A

Accepts Healthy Volunteers

No

Contacts

Koudou Ishii, M.D., , 

NCT ID

NCT00212355

Organization ID

NPC-02-2

Responsible Party

Sponsor

Study Sponsor

Nobelpharma

Study Sponsor

Koudou Ishii, M.D., Study Director, National MINAMIYOKOHAMA Hospital

Verification Date

April 2019