NCT01828463已完成2 期
An International, Multicentre, Randomised, Open-label, No-treatment Controlled, Parallel-group, Dose-response Study to Investigate the Effect of Once Daily Nitisinone on 24-hour Urinary Homogentisic Acid Excretion in Patients With Alkaptonuria After 4 Weeks Treatment.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- dose of nitisinone that decreases urinary homogentisic acid to near normal
研究概览
简要总结
SONIA 1 is an international, multicentre, randomised, open-label, no-treatment controlled, parallel group, dose-response study to investigate the effect of once daily nitisinone on 24-hour urinary homogentisic acid excretion in patients with alkaptonuria after 4-weeks treatment. They study will identify the optimal dose to decrease urine homogentisic acid to near normal levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Nitisinone 2mg
Experimental
interventional
干预措施: Nitisinone (Drug)
Nitisinone 1mg
Experimental
interventional
干预措施: Nitisinone (Drug)
Nitisinone 4mg
Experimental
interventional
干预措施: Nitisinone (Drug)
Nitisinone 8mg
Experimental
interventional
干预措施: Nitisinone (Drug)
结局指标
主要结局
dose of nitisinone that decreases urinary homogentisic acid to near normal
时间窗: 4 weeks
次要结局
未报告次要终点
研究者
Professor Lakshminarayan Ranganath
Consultant in Metabolic medicine
University of Liverpool
研究点 (1)
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