NCT03404856Unknown1 期
Study of ORL-1G (D-galactose) in Patients With Glycogen Storage Disease Type 14
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- Orpha Labs
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Improvement in liver function.
研究概览
简要总结
Study of ORL-1G in Patients With Glycogen Storage Disease Type 14
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
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Glycogen Storage Disease Type
- •Less than 18 years old.
排除标准
- •Diagnosis of any other disease that is not a manifestation of Glycogen Storage Disease Type 14.
研究组 & 干预措施
Treatment with ORL-1G - D-galactose
Other
干预措施: ORL-1G - D-galactose (Drug)
结局指标
主要结局
Improvement in liver function.
时间窗: 3 months after treatment starts
Statistically significant decrease in plasma liver enzyme levels
次要结局
- Improvement in serum transferrin glycosylation pattern.(30 days after treatment starts)
研究者
研究点 (1)
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