NCT05904626招募中2 期
A Multi-center, Double-Blind, Randomized, Two-Arm, Parallel-Group, Placebo Controlled Basket Study to Assess the Safety of ELGN-2112 in Preterm Infants Born Under 26 Weeks GA and IUGR Infants Born 26-32 Weeks GA
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Compare the safety of treatment with ELGN-2112 to placebo in preterm infants born less than 26 weeks GA
研究概览
简要总结
To compare the safety of treatment with ELGN-2112 to placebo in preterm infants born less than 26 weeks GA and IUGR infants<3rd percentile* born at 26-32 weeks GA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 5 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female preterm infant born less than 26 weeks GA or Intra-Uterine Growth Restricted infants born between 26+0 to 31+6 GA.
- •Birth weight ≥ 450g
- •Singleton or twin birth
排除标准
- 未提供
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
ELGN-2112 Human insulin [rDNA]
Active Comparator
干预措施: ELGN-2112 (Drug)
结局指标
主要结局
Compare the safety of treatment with ELGN-2112 to placebo in preterm infants born less than 26 weeks GA
时间窗: Five days from birth until 42 days
Safety will be assessed by capturing of adverse events (AEs) during the treatment period.
Compare the safety of treatment with ELGN-2112 to placebo in preterm infants born IUGR infants<3rd percentile* born at 26-32 weeks GA.
时间窗: Five days from birth until 42 days
Safety will be assessed by capturing of adverse events (AEs) during the treatment period.
次要结局
未报告次要终点
研究者
研究点 (1)
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