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NCT00212355 Clinical Trial

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

Wilson's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00212355
Other study ID # NPC-02-2
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date March 2005
Est. completion date January 2009

Study information
Verified date April 2019
Source Nobelpharma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 37
Est. completion date January 2009
Est. primary completion date April 2008
Accepts healthy volunteers No
Gender All
Age group 1 Year and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Acute hepatitis

- Malignant tumor

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• NPC-02
zinc acetate

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Nobelpharma

References & Publications (1)

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, an — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Safety and Efficacy Number of patients who have at least one adverse events. ALT Change During study period (up to 96W )
See also
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