A Randomised, Double Blind, Multi-center, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of NT100 in Pregnant Women With a History of Unexplained Recurrent Pregnancy Loss (RPL)
试验速览
- 阶段
- 2 期
- 入组人数
- 150
- 主要终点
- Clinical Pregnancy
研究概览
简要总结
This is a randomised, double blind, multi-center, placebo-controlled study of subcutaneous NT100 in pregnant women with a history of unexplained recurrent pregnancy loss. Approximately 150 participants will be randomised to receive subcutaneous NT100 or placebo.
详细描述
This is a randomised, double blind, multi-center, placebo-controlled study of subcutaneous NT100 in pregnant women with a history of unexplained recurrent pregnancy loss. Approximately 150 participants will be randomised to receive subcutaneous NT100 or placebo. Participants will be screened for eligibility, and will begin attempts at spontaneous conception. Following randomization and initiation of study drug treatment, participants will visit the study site at specified intervals throughout the study for assessments and blood work.
All participants will be monitored for adverse events. All participants who have received at least one dose of study drug will be followed for safety for a minimum of 4 weeks following the last dose of study drug. After delivery, pregnancy outcome information will be obtained.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 37 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pre-menopausal female 18-37 years of age at consent, trying to conceive
- •Documented history of unexplained recurrent pregnancy loss
- •Spontaneous conception, as confirmed by urine pregnancy test performed at the investigative site
- •Body mass index (BMI) of 19-35 kg/m2 at consent
排除标准
- •Greater than 5 weeks of gestation when presenting for randomisation.
- •Known karyotype abnormalities in either the participant or her current male partner
- •Uncorrected clinically significant intrauterine abnormalities
- •Abnormal vaginal bleeding of unknown cause
- •Current diagnosis of infertility in either the participant or her current male partner
- •Current or past diagnosis of systemic autoimmune disease, coagulopathy, hyperprolactinemia, cervical incompetence, or high-grade cervical dysplasia with conization/surgery.
- •Any uncontrolled clinically significant medical condition
研究组 & 干预措施
NT100
NT100 Dose 1
干预措施: NT100 (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Clinical Pregnancy
时间窗: at Week 20 of gestation
The primary outcome measure is clinical pregnancy at Week 20 of gestation
次要结局
- Live birth(at any time during pregnancy)
- Clinical pregnancy(at Weeks 6, 8 and 12 of gestation)
- Spontaneous pregnancy loss(within 24 weeks of gestation)
- Stillbirth(after 24 weeks of gestation)
- Subjects with adverse events and serious adverse events(during treatment and within 4 weeks after treatment)
- Changes in clinical laboratory parameters following study drug exposure(during treatment and within 4 weeks after treatment)