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

NCT ID: NCT00212355

Last Updated: 2025-03-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2009-01-31

Brief Summary

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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

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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.

Conditions

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Wilson's Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NPC-02

zinc acetate

Group Type EXPERIMENTAL

NPC-02

Intervention Type DRUG

zinc acetate

Interventions

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NPC-02

zinc acetate

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Acute hepatitis
* Malignant tumor
Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nobelpharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Koudou Ishii, M.D.

Role: STUDY_DIRECTOR

National MINAMIYOKOHAMA Hospital

References

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Shimizu N, Fujiwara J, Ohnishi S, Sato M, Kodama H, Kohsaka T, Inui A, Fujisawa T, Tamai H, Ida S, Itoh S, Ito M, Horiike N, Harada M, Yoshino M, Aoki T. Effects of long-term zinc treatment in Japanese patients with Wilson disease: efficacy, stability, and copper metabolism. Transl Res. 2010 Dec;156(6):350-7. doi: 10.1016/j.trsl.2010.08.007. Epub 2010 Sep 23.

Reference Type RESULT
PMID: 21078496 (View on PubMed)

Other Identifiers

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NPC-02-2

Identifier Type: -

Identifier Source: org_study_id

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