jRCTs021200008已完成不适用
Phase II study of galactosidase as therapy for type IV galactosemia
未提供0 个研究点目标入组 8 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Crossover Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 1age 0month 0week old over 至 10age 0month 0week old not（—）
- 性别
- All
入选标准
- •Patients are diagnosed to type IV galactosemia by genetic test (pathogenic variants in GALM gene are identified by exome or direct sequencing) or GALM enzyme activity test.
排除标准
- •(1) Patients with severe liver disease or liver injury (AST, ALT > 1.25 x upper limits of normal)
- •(2) Patients have participated to other clinical study or trial
- •(3) Patients with constipation which is in need of treat
- •(4) Patients with psychological problem
结局指标
主要结局
-
Blood galactose levels at 2 or 3 hours after lactose loading
次要结局
- Difference between peak level of blood galactose and minimum level of blood galactose after 30 minutes after lactose loading(30 minutes after lactose loading)
- Peak level of blood galactose
- Peak level of urine galactitol
研究者
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