PoC Study of OBE022 in Threatened Preterm Labour
- Registration Number
- NCT03369262
- Lead Sponsor
- ObsEva SA
- Brief Summary
This is a proof-of-concept study in 2 parts.
In Part A, patients will receive OBE022 open-label in order to assess the safety and pharmacokinetics in pregnant women with spontaneous preterm labour with a gestational age between 28 0/7 and 33 6/7 weeks.
Part B has a double-blind, randomised, placebo controlled, parallel group and multicentre design and will assess the efficacy, safety and pharmacokinetics in pregnant women with threatened spontaneous preterm labour with a gestational age between 24 0/7 and 33 6/7 weeks.
All patients in part A and part B must receive atosiban infusion for 48 hours as standard of care treatment. Patients from Part A will receive OBE022 open label. Patients from Part B will be randomised to receive OBE022 or matching placebo. IMP treatment duration will be up to 7 days. IMP treatment will be stopped in case of delivery prior to Day 7.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 115
Part A
- Pregnant females aged ≥ 18 years
- Patients with a singleton or twin pregnancy
- Gestational age between 28 0/7 and 33 6/7
- Administered or prescribed atosiban for the treatment of preterm labour
Part B
-
Pregnant females aged ≥ 18 years
-
Patients with a singleton or twin pregnancy
-
Gestational age between 24 0/7 and 33 6/7
-
Administered or prescribed atosiban for the treatment of preterm labour
-
≥4 uterine contractions per 30 minutes
-
Cervical dilatation of 1 to 4 cm inclusive
-
At least one of the following signs of preterm labour:
- positive IGFBP-1 or fœtal Fibronectin test
- cervical length ≤ 25mm
- progressive cervical change
Key
-
Fœtal death in utero in current or previous pregnancy after gestational week 24 or expected high risk of fœtal death in the coming days
-
Oligohydramnios
-
Known pathological Doppler ultrasound of the umbilical artery
-
Any contraindications for the mother or the fœtus to stop labour or prolong pregnancy or any maternal or fœtal conditions likely to indicate iatrogenic delivery in the next 7 days, including but not limited to:
- Premature rupture of membranes
- Evidence or suspicion of abruptio placenta
- Signs and/or symptoms of chorio-amnionitis
- Pre-eclampsia, eclampsia or HELLP-syndrome
-
Use of cervical cerclage in the current pregnancy or a pessary in situ
-
Current use of anti-hypertensive medication
-
Treatment with other tocolytics within specified time before the baseline assessment of uterine contractions
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebos OBE022 matching placebo plus atosiban: OBE022 matching placebo administration will follow the same regimen as the active group. Atosiban will be administered over 48h as per label. Active OBE022 OBE022 plus atosiban: OBE022 will be given orally from Day 1 to Day 7. OBE022 treatment will be initiated ideally simultaneously or at a maximum within 24 h after atosiban start. * Loading dose: 1 000 mg on Day 1. * Maintenance dose on Day 1: 500 mg in the evening if loading dose was administered in the morning. If loading dose was administered in the afternoon, then the next dose will take place on the morning of Day 2. * Maintenance dose from Day 2 to Day 7: 500 mg twice a day (only morning dose on Day 7) Atosiban will be administered over 48h as per label. Active Atosiban OBE022 plus atosiban: OBE022 will be given orally from Day 1 to Day 7. OBE022 treatment will be initiated ideally simultaneously or at a maximum within 24 h after atosiban start. * Loading dose: 1 000 mg on Day 1. * Maintenance dose on Day 1: 500 mg in the evening if loading dose was administered in the morning. If loading dose was administered in the afternoon, then the next dose will take place on the morning of Day 2. * Maintenance dose from Day 2 to Day 7: 500 mg twice a day (only morning dose on Day 7) Atosiban will be administered over 48h as per label. Placebo Atosiban OBE022 matching placebo plus atosiban: OBE022 matching placebo administration will follow the same regimen as the active group. Atosiban will be administered over 48h as per label.
- Primary Outcome Measures
Name Time Method Incidence of delivery within 2 days (48 h) from start of IMP administration 48 hours Incidence of delivery within 7 days (168 h) from start of IMP administration 168 hours Incidence of delivery before 37 weeks of GA Up to 13 weeks from start of IMP administration Time to delivery measured from start of IMP administration Up to 17 weeks from start of IMP administration
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (18)
Rabin Medical Center, Fetal-Maternal Medicine, Helen Schneider's Hospital for Women
🇮🇱Petah tikva, Israel
Rambam Medical Center, Maternal Fetal Unit
🇮🇱Haifa, Israel
Gynekologicko-porodnická klinika Fakultní nemocnice Brno
🇨🇿Brno, Czechia
Gynekologicko-porodnická klinika 1. LF UK a VFN v Praze
🇨🇿Praha, Czechia
Ústav pro péči o matku a dítě
🇨🇿Praha, Czechia
Hilel Yafe Medical Center, Maternal Fetal Unit
🇮🇱Haifa, Israel
Helsinki Universisty Hospital
🇫🇮Helsinki, Finland
Meir Medical Center, Obstetrics and Gynecology Department
🇮🇱Kfar Saba, Israel
Moscow Regional Perinatal Center
🇷🇺Balašicha, Russian Federation
Kazan State Medical University
🇷🇺Kazan, Russian Federation
Hospital La Paz
🇪🇸Madrid, Spain
Perinatal center of the City Clinical Hospital #24
🇷🇺Moscow, Russian Federation
City clinical hospital № 15 named after O. M. Filatov of Healthcare Department of Moscow
🇷🇺Moscow, Russian Federation
Hospital Clínico Universitario de Santiago
🇪🇸Santiago De Compostela, Spain
Hospital Clínico Universitario Virgen de la Arrixaca
🇪🇸Murcia, Spain
Hanoi Obstetrics and Gynecology Hospital
🇻🇳Hanoi, Vietnam
Hospital Universitari i Politècnic La Fe
🇪🇸Valencia, Spain
My Duc Hospital
🇻🇳Ho Chi Minh City, Vietnam