NCT00212355已完成3 期
Phase3, Open-Label, Clinical Trial of Zinc Acetate for Treatment of Wilson's Disease in Japan.
Nobelpharma0 个研究点目标入组 37 人开始时间: 2005年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 主要终点
- Safety and Efficacy
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Wilson's disease(adult, infant, pregnant woman)
排除标准
- •Acute hepatitis
- •Malignant tumor
研究组 & 干预措施
NPC-02
Experimental
zinc acetate
干预措施: NPC-02 (Drug)
结局指标
主要结局
Safety and Efficacy
时间窗: During study period (up to 96W )
Number of patients who have at least one adverse events. ALT Change
次要结局
未报告次要终点
研究者
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