NCT02326142终止2 期
A Phase 2, Double-blind, Parallel Group, Randomised, Placebo Controlled, Proof of Concept Study to Assess the Safety and Efficacy of OBE001 After Oral Administration in Pregnant Women With Threatened Preterm Labour.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- ObsEva SA
- 入组人数
- 10
- 主要终点
- EFFICACY ENDPOINTS: Incidence of women delivering within 7 days post first dose
研究概览
简要总结
The primary objective of this study is to assess the efficacy of a single dose of OBE001, an oral oxytocin antagonist, given for up to 7 days to delay preterm birth by 7 days compared to placebo.
详细描述
The study will be a multi-centre, randomised, parallel group, double-blind, placebo-controlled study in pregnant women with threatened preterm labour between 34^0/7 and 35^6/7 weeks of gestation.
The study will be in 2 parts as follows:
- from screening until the day of delivery (including a treatment period up to seven days)
- a maternal and neonatal follow-up period from the day of delivery until 28 days post expected term date (or until 28 days post-delivery should this be later).
In addition, there will be an observational, safety follow-up of the infants for 2 years to evaluate developmental outcome.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Gestational age (GA) between 34^0/7 and 35^6/7 weeks.
- •Subjects with symptoms of preterm labour.
- •Subjects with a singleton pregnancy.
排除标准
- •Foetal death in utero in current pregnancy or in previous pregnancy after gestational week 24 or expected high risk of foetal death in the current pregnancy.
- •Any contraindications for the mother or the foetus to stop labour or prolong pregnancy or any maternal or foetal conditions likely to indicate iatrogenic delivery.
- •Use of cervical cerclage or a pessary in situ in the current pregnancy.
- •The Subject has any condition which in the opinion of the PI constitutes a risk or a contraindication for the participation of the subject in the trial.
研究组 & 干预措施
OBE001
Experimental
干预措施: OBE001 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
EFFICACY ENDPOINTS: Incidence of women delivering within 7 days post first dose
时间窗: within 7 days of first dose
次要结局
- EFFICACY ENDPOINTS: Incidence of women delivering within 48 hours post first dose(within 48 hours of first dose)
- EFFICACY ENDPOINTS: Incidence of women delivering before gestational age 37^0/7 weeks(up to 3 weeks post first dose)
- EFFICACY ENDPOINTS: Progression of uterine contractions from pre-dose to 6 hours and 24 hours post first dose(up to 24 hours post first dose)
- EFFICACY ENDPOINTS: Assessment of maternal and foetal exposure to OBE001 (Maternal plasma concentrations of OBE001)(up to 7 weeks post first dose)
研究者
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