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

Phase 3

Completed

• Conditions: Wilson's Disease
• Interventions: Drug: NPC-02

• Registration Number: NCT00212355
• Lead Sponsor: Nobelpharma

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 Timeline

• Study Start: 2005-03
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Primary Completion: 2008-04
• Study Completion: 2009-01
• Results First Submitted: 2014-04-09
• Results First Submitted QC: 2014-04-10
• Results First Posted: 2014-05-14
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

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

Exclusion Criteria

• Acute hepatitis
• Malignant tumor

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NPC-02	NPC-02	zinc acetate

Primary Outcome Measures

Name	Time	Method
Safety and Efficacy	During study period (up to 96W )	Number of patients who have at least one adverse events. ALT Change