NCT02472769已完成2 期
A Randomized, Double Blind, Parallel-group, Dose Escalation Placebo-controlled Multicenter Study to Investigate the Safety and Tolerability of IBP-9414 Administered in Preterm Infants.
Infant Bacterial Therapeutics15 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2016年5月27日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 15
- 主要终点
- Safety and Tolerability of IBP-9414 as the observed number of adverse events (AE) and serious adverse events (SAE)
研究概览
简要总结
Two different dose levels will be evaluated in two different birth weight categories, compared to placebo with regards to safety and tolerability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 48 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age ≤32 weeks
- •Birth weight: a) ≤ 2,000 g and b) ≤ 1,000 g.
- •< 48 hours of age.
- •Written informed consent from the patient's legally authorized representative(s).
排除标准
- •Participation in an additional interventional clinical trial in which an investigational drug will be administered.
- •Infants in extremis to whom no further intensive care is offered by attending neonatologist (e.g., infant being provided only hospice/comfort care).
- •Congenital or acquired gastrointestinal pathology.
- •Other conditions of the infant, which in the opinion of the attending neonatologist, preclude participation.
研究组 & 干预措施
IBP-9414
Active Comparator
IBP-9414 Oral Daily
干预措施: IBP-9414 (Drug)
Placebo
Placebo Comparator
Sterile water
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and Tolerability of IBP-9414 as the observed number of adverse events (AE) and serious adverse events (SAE)
时间窗: 12 months
次要结局
未报告次要终点
研究者
研究点 (15)
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