NCT02865122终止2 期
A Multi-Center, Randomized, Double-Blind, Three-Arm, Parallel-Group Trial to Assess the Efficacy and Safety of NTRA-9620 in Infants With Short Bowel Syndrome (SBS) Following Surgical Resection
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 8
- 主要终点
- Percent Change in %PN/IV
研究概览
简要总结
The objective of this clinical study is to evaluate the efficacy and safety of NTRA-9620 compared with placebo in pediatric subjects (aged 28 weeks postmenstrual age to 52 weeks old) with SBS following surgical resection
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Weeks 至 52 Weeks（Child）
- 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
NTRA-9620-A
Experimental
NTRA-9620 Dose 1 To be dosed orally for 24 weeks, 4 times/day
干预措施: NTRA-9620 (Drug)
NTRA-9620-B
Experimental
NTRA-9620 Dose 2 To be dosed orally for 24 weeks, 4 times/day
干预措施: NTRA-9620 (Drug)
Placebo
Placebo Comparator
Placebo To be dosed orally for 24 weeks, 4 times/day
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change in %PN/IV
时间窗: baseline and end of treatment or 24 weeks, whichever occurs first
Percent change in %PN/IV from baseline based on caloric intake
次要结局
未报告次要终点
研究者
研究点 (8)
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