A Multicenter, Randomized, Patient, Investigator and Sponsor Blinded, Placebo-controlled Phase II Study to Evaluate the Efficacy and Safety of CSJ148 in Pregnant Women With Primary HCMV Infection
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Event rate of fetuses or neonates with congenital human cytomegalovirus (HCMV) infection
研究概览
简要总结
The purpose of the study is to evaluate the feasibility of using CSJ148 to prevent congenital human cytomegalovirus (HCMV) in pregnant women with primary HCMV infection.
详细描述
This is a randomized, patient, investigator and sponsor blinded, placebo-controlled study in pregnant women with primary HCMV infection. The study has three periods: (I) screening (II) double-blinded placebo-controlled treatment and (III) post-delivery follow-up of women and neonates/infants. Pregnant women with confirmed primary HCMV infection will participate in periods I and II. Mothers and neonates/infants born to mothers enrolled in the study will participate in period III.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
This is a patient, investigator and sponsor-blinded study. Patients, investigators and sponsor will remain blinded to study treatment throughout the study.
With the exception of any unblinded site staff identified below, all site staff (including study investigator and study nurse) will be blinded to study treatment throughout the study.
Drug product will be supplied in patient specific kits, so an unblinded pharmacist who is independent of the study team will be required in order to maintain the blind. Appropriate measures must be taken by the unblinded pharmacist to ensure that the treatment assignments are concealed from the rest of the site staff.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Written informed consent must be obtained before any assessment is performed.
- •Pregnant women ≥ 18 years of age with primary HCMV infection occurring between 6 and 24 weeks of gestation
- •Ability to receive study drug within 6 weeks of the presumed onset of primary maternal infection.
- •Able to communicate well with the investigator, to understand and comply with the requirements of the study.
排除标准
- •Confirmed or suspected fetal HCMV infection, defined as positive HCMV DNA in amniotic fluid or fetal ultrasound abnormalities suggestive of fetal HCMV disease.
- •Prior treatment with any of the following within 30 days prior to enrollment: ganciclovir, valganciclovir, foscarnet, cidofovir, acyclovir (>25 mg/kg/day IV), valacyclovir (>3 gm/day oral), famciclovir (>1500 mg/day oral), HCMV immune globulin, immune globulin (>500 mg/kg), or any other medication with anti-HCMV activity.
- •Any surgical or medical condition (other than pregnancy) which might increase the risk for thrombotic events if the patient is given immune-globulins. These conditions include cryoglobulinemia, monoclonal gammopathies, and hypertriglyceridemia (fasting level >1000 mg/dL). The investigator should make this determination based on the patient's medical history and laboratory data.
- •History of chronic hepatitis B, hepatitis C and human immunodeficiency virus (HIV) infection. Cured hepatitis C in not considered exclusionary.
- •Patient request for medical interruption or termination of pregnancy before inclusion.
- •Any surgical or medical condition which may jeopardize the patient or fetus in case of participation in the study. The investigator should make this determination in consideration of the patient's obstetrical history.
- •Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or until the expected pharmacodynamic effect has returned to baseline, whichever is longer; or longer if required by local regulations.
- •History of hypersensitivity to any of the study treatments or excipients or to drugs of similar chemical classes.
- •Body weight > 100 kilograms.
研究组 & 干预措施
Placebo
5% dextrose
干预措施: Placebo (Other)
Active
CSJ148
干预措施: CSJ148 (Biological)
结局指标
主要结局
Event rate of fetuses or neonates with congenital human cytomegalovirus (HCMV) infection
时间窗: Day 218
To assess the efficacy of CSJ148 on reducing intrauterine HCMV transmission compared to placebo
次要结局
- CSJ148 concentration in cord blood(Day 218)
- Immunogenicity of CSJ148 in pregnant women(Days 1,29,57,85,218,141,169, 197, 218)
- Immunogenicity of CSJ148 in cord blood(Day 218)
- CSJ148 concentration in amniotic fluid(Day 218)
- Change from Baseline in the Reduction in symptomatic congenital human cytomegalovirus (HCMV) disease (compared to placebo)(Day 218)
- Change from baseline in congenital human cytomegalovirus (HCMV) urine viral load in neonates at birth(Baseline, Day 218)
- Pharmacokinetic concentration data of CSJ148(Days 1,29,57,85,218,141,169, 197, 218)