EUCTR2017-002579-25-FI进行中（未招募）1 期
A phase 2a, double-blind, parallel group, randomised, placebo controlled, proof of concept study to assess the efficacy, safety and pharmacokinetics of OBE022 added-on to atosiban, after oral administration in pregnant women with threatened spontaneous preterm labour - PROLONG
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- ObsEva SA
- 入组人数
- 130
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1. Provision of written informed consent to participate as shown by a signature on the patient consent form
- •2. Be able and willing to comply with the requirements of the protocol
- •3. Pregnant females aged = 18 years
- •4. Patients with a singleton or twin pregnancy
- •5. Gestational age between 28 (0/7) and 33 (6/7), as confirmed by a first trimester ultrasound scan or fertilization date. In situations where this information is not readily available, Investigator may use best clinical judgement or verbal history from the patient to be confirmed through medical records as soon as possible after inclusion
- •6. Administered or prescribed atosiban for the treatment of preterm labour (note that IMP treatment should be initiated ideally simultaneously or at a maximum within 24 h after atosiban start)
- •1. Provision of written informed consent to participate as shown by a signature on the patient consent form
- •2. Be able and willing to comply with the requirements of the protocol
- •3. Pregnant females aged = 18 years.
- •4. Patients with a singleton or twin pregnancy
- •5. Gestational age between 24 (0/7) and 33 (6/7), as confirmed by a first trimester US scan or fertilization date. In situations where this information is not readily available, the Investigator may use best clinical judgement or verbal history from the patient to be confirmed through medical records as soon as possible after randomisation
- •6. =4 uterine contractions per 30 minutes, measured by electrohysterography, tocodynamometry or abdominal palpation *
- •7. Cervical dilatation of 1 to 4 cm inclusive *
- •8. At least one of the following signs of preterm labour * :
- •a) positive IGFBP-1 or fœtal Fibronectin test
- •b) cervical length = 25mm
- •c) progressive cervical change
- •9. Administered or prescribed atosiban for the treatment of preterm labour (note that IMP treatment should be initiated ideally simultaneously or at a maximum within 24 h after atosiban start)
- •* For criteria 6, 7 and 8, each criterion must be met at least once anytime between the 3 hours preceding atosiban start and first IMP intake.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 130
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •To be eligible for inclusion in this study the patients must not meet any of the following criteria:
- •1. Fœtal death in utero in current or previous pregnancy after gestational week 24 or expected high risk of fœtal death in the coming days
- •2. Fœtal weight outside 2 standard deviations for GA based on ultrasound
- •3. Oligohydramnios
- •4. Known pathological Doppler ultrasound of the umbilical artery
- •5. 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:
- •a) Premature rupture of membranes
- •b) Evidence or suspicion of abruptio placenta
- •c) Signs and/or symptoms of chorio-amnionitis
- •d) Pre-eclampsia, eclampsia or HELLP-syndrome
- •6. Any condition which in the opinion of the Investigator constitutes a risk or a contraindication for the participation of the patient in the trial or that could interfere with the trial objectives, conduct or evaluation, including:
- •a) Any clinically significant abnormality in the results of the screening safety laboratory tests, including AST, ALT, GGT or total bilirubin > ×2 ULN
- •b) Any clinically significant and trial relevant abnormality in the results of the screening physical examination including a gynaecological examination
- •7. The patient has known positive results from virology tests for HBsAg (not due to vaccination), HCV or HIV 1 or 2. However, patients who have resolved hepatitis B infection may be enrolled in the study
- •8. The patient had a BMI = 35 kg/m2 prior to start of current pregnancy or had a bariatric surgery
- •9. Any condition likely to hinder drug absorption
- •10. Use of cervical cerclage in the current pregnancy or a pessary in situ (not applicable in Part A)
- •11. Current use of anti-hypertensive medication
- •12. Treatment with other tocolytics within specified time before the baseline assessment of uterine contractions i.e.
- •a) nifedipine (not long acting) in the previous 6 hours
- •b) ritodrine, fenoterol, other betamimetics, indomethacin, other oral or injectable NSAIDs, long acting nifedipine, other calcium channel blockers, and nitric oxide donors in the previous 24 hours
- •c) nicardipine in the previous 2 weeks
- •d) any other drug given for tocolysis (within 5 half-lives of the agent before IMP start)
- •13. Known allergy or hypersensitivity to the active substance or any of the ingredients of the study drug
- •14. History of or current (within the past 12 months) known problem with alcohol or drug abuse
- •15. Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study, and/or evidence of uncooperative attitude
- •16. Currently participating or have participated in another clinical trial (investigational drug or medical device) within 30 days prior to screening
研究者
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