Back to resultsA Phase 2 Study of OBE001 Versus Placebo in the Delay of Preterm Birth (TERM)
Primary Purpose
Preterm Labor
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
OBE001
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Preterm Labor focused on measuring Premature Obstetric Labor, Premature Birth
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
OBE001
Placebo
Arm Description
Outcomes
Primary Outcome Measures
EFFICACY ENDPOINTS: Incidence of women delivering within 7 days post first dose
Secondary Outcome Measures
EFFICACY ENDPOINTS: Incidence of women delivering within 48 hours post first dose
EFFICACY ENDPOINTS: Incidence of women delivering before gestational age 37^0/7 weeks
EFFICACY ENDPOINTS: Progression of uterine contractions from pre-dose to 6 hours and 24 hours post first dose
Contractions measured by tocodynamometry.
EFFICACY ENDPOINTS: Assessment of maternal and foetal exposure to OBE001 (Maternal plasma concentrations of OBE001)
Maternal plasma concentrations of OBE001 on Day 1 (2 hours post first dose), on Day 2 (pre-dose and 2 hours post-dose) on Day 3 (pre-dose), Day 7 (post-dose) and at the time of delivery. Umbilical cord plasma concentration of OBE001 at the time of delivery.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02326142
Brief Title
A Phase 2 Study of OBE001 Versus Placebo in the Delay of Preterm Birth
Acronym
TERM
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
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Terminated
Why Stopped
Enrolment difficulties.
Study Start Date
March 2015 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ObsEva SA
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Labor
Keywords
Premature Obstetric Labor, Premature Birth
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OBE001
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
OBE001
Intervention Description
OBE001 dispersible tablets for a single oral dose a day for up to 7 days.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo dispersible tablets for a single oral dose a day for up to 7 days.
Primary Outcome Measure Information:
Title
EFFICACY ENDPOINTS: Incidence of women delivering within 7 days post first dose
Time Frame
within 7 days of first dose
Secondary Outcome Measure Information:
Title
EFFICACY ENDPOINTS: Incidence of women delivering within 48 hours post first dose
Time Frame
within 48 hours of first dose
Title
EFFICACY ENDPOINTS: Incidence of women delivering before gestational age 37^0/7 weeks
Time Frame
up to 3 weeks post first dose
Title
EFFICACY ENDPOINTS: Progression of uterine contractions from pre-dose to 6 hours and 24 hours post first dose
Description
Contractions measured by tocodynamometry.
Time Frame
up to 24 hours post first dose
Title
EFFICACY ENDPOINTS: Assessment of maternal and foetal exposure to OBE001 (Maternal plasma concentrations of OBE001)
Description
Maternal plasma concentrations of OBE001 on Day 1 (2 hours post first dose), on Day 2 (pre-dose and 2 hours post-dose) on Day 3 (pre-dose), Day 7 (post-dose) and at the time of delivery. Umbilical cord plasma concentration of OBE001 at the time of delivery.
Time Frame
up to 7 weeks post first dose
Other Pre-specified Outcome Measures:
Title
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)
Description
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 from Day 1 until 28 days after birth or term whichever is later.
Time Frame
up to 28 days post expected term date
Title
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)
Description
Incidence of foetal distress as determined by clinically significant changes in growth retardation and/or foetal heart rate monitoring and/or Amniotic Fluid Indices (AFI) from Day 1 to Day 14 or birth, whichever is earlier
Time Frame
up to 14 days post first dose or birth whichever is earlier
Title
SAFETY ENDPOINTS: Evaluation of the newborn neonatal morbidity
Description
Incidence of infants experiencing adverse events assessed by vital signs, temperature, APGAR score, weight and head circumference at birth as well as measures of neonatal morbidity from birth until 28 days after birth or term whichever is later
Time Frame
up to 28 days post expected term date
Title
SAFETY ENDPOINTS: Evaluation of infant neurodevelopmental outocme.
Description
Incidence of infants with one or more Ages and Stages Questionnaire-3 domain score(s) below the cutoff at 6, 12, and 24 months, adjusted for gestational age.
Time Frame
up to 2 years after birth
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
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
12. IPD Sharing Statement
Learn more about this trial
A Phase 2 Study of OBE001 Versus Placebo in the Delay of Preterm Birth
We'll reach out to this number within 24 hrs