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

Nobelpharma Co., Ltd.

Status and phase: Completed; Phase 3

Conditions: Wilson's Disease

Treatments: Drug: NPC-02

Study type: Interventional

Funder types: Industry

Identifiers

NCT00212355

NPC-02-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 37 patients

Sex: All

Ages: 1+ year old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Acute hepatitis
• Malignant tumor

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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37 participants in 1 patient group

NPC-02

Experimental group

Description:

zinc acetate

Treatment:

Drug: NPC-02