Clinical trial NCT02326142: A Phase 2 Study of OBE001 Versus Placebo in the Delay of Preterm Birth
Official title: 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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Preterm Labor
Keywords: Premature Obstetric Labor
Premature Birth
Lead sponsor: ObsEva SA
Sponsor class: INDUSTRY
First posted: 2014-12-25
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: EFFICACY ENDPOINTS: Incidence of women delivering within 7 days post first dose
timeFrame: within 7 days of first dose
Secondary outcomes:
measure: EFFICACY ENDPOINTS: Incidence of women delivering within 48 hours post first dose
timeFrame: within 48 hours of first dose
measure: EFFICACY ENDPOINTS: Incidence of women delivering before gestational age 37^0/7 weeks
timeFrame: up to 3 weeks post first dose
measure: EFFICACY ENDPOINTS: Progression of uterine contractions from pre-dose to 6 hours and 24 hours post first dose
timeFrame: up to 24 hours post first dose
measure: EFFICACY ENDPOINTS: Assessment of maternal and foetal exposure to OBE001 (Maternal plasma concentrations of OBE001)
timeFrame: up to 7 weeks post first dose
Other outcomes:
measure: SAFETY ENDPOINTS: Evaluation of the maternal safety of OBE001 (Maternal incidence of adverse events (AEs), treatment-emergent adverse events (TEAEs), clinically significant changes in laboratory safety tests, 12-lead ECGs morphology or vital signs)
timeFrame: up to 28 days post expected term date
measure: SAFETY ENDPOINTS: Evaluation of the foetal safety of OBE001 (clinically significant changes in growth retardation and/or foetal heart rate monitoring and/or Amniotic Fluid Indices (AFI)
timeFrame: up to 14 days post first dose or birth whichever is earlier
measure: SAFETY ENDPOINTS: Evaluation of the newborn neonatal morbidity
timeFrame: up to 28 days post expected term date
measure: SAFETY ENDPOINTS: Evaluation of infant neurodevelopmental outocme.
timeFrame: up to 2 years after birth
Locations:
city: Brussels
country: Belgium
city: Leuven
country: Belgium
city: Liege
country: Belgium
city: Bayreuth
country: Germany
city: Dusseldorf
country: Germany
city: Tuebingen
country: Germany
city: Ulm
country: Germany
city: Bialystok
country: Poland
city: Chorzow
country: Poland
city: Lodz
country: Poland
city: Ruda Slaska
country: Poland
city: Warsaw
country: Poland
city: Barcelona
country: Spain
city: El Palmar
country: Spain
city: Madrid
country: Spain
city: Vitoria - Gasteiz
country: Spain
city: Zaragoza
country: Spain
city: Basel
country: Switzerland
city: Bern
country: Switzerland
city: Geneva
country: Switzerland
city: Lausanne
country: Switzerland
city: Leeds
country: United Kingdom
city: London
country: United Kingdom
Study officials:
References: