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.
Overview
- Phase
- Phase 2
- Intervention
- OBE001
- Conditions
- Preterm Labor
- Sponsor
- ObsEva SA
- Enrollment
- 10
- Primary Endpoint
- EFFICACY ENDPOINTS: Incidence of women delivering within 7 days post first dose
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Gestational age (GA) between 34\^0/7 and 35\^6/7 weeks.
- •Subjects with symptoms of preterm labour.
- •Subjects with a singleton pregnancy.
Exclusion Criteria
- •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.
Arms & Interventions
OBE001
Intervention: OBE001
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
EFFICACY ENDPOINTS: Incidence of women delivering within 7 days post first dose
Time Frame: within 7 days of first dose
Secondary Outcomes
- 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)