NCT05170269终止3 期
Prevention of Maternal-fetal Cytomegalovirus Transmission After Primary Maternal Infection With Gestational Age ≤ 14 Weeks - an Open-label, Single-arm, Prospective Trial Investigating Efficacy and Safety of Cytotect CP Biotest
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Biotest
- 入组人数
- 48
- 试验地点
- 5
- 主要终点
- To determine the overall rate of maternal-fetal transmission at the time of amniocentesis (week 20 [-1 week / +2 weeks] of gestation)
研究概览
简要总结
A phase 3, open-label, single-arm, prospective, multi-center trial of Cytotect CP Biotest (BT097) for prevention of maternal-fetal CMV transmission after primary maternal CMV infection. The main purpose of the trial is to demonstrate efficacy and safety of Cytotect CP Biotest in preventing maternal-fetal transmission of cytomegalovirus (CMV).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Written informed consent obtained from subjects indicating that they understand the purpose of and procedures required for the trial and are willing to participate in it
- •Pregnant women, age 18 to 45 years
- •Pregnant women at trial entry with gestational age ≤14 weeks; pregnancy after in-vitro fertilization permitted
- •Detection of early primary CMV infection
排除标准
- •Women with current multiple pregnancy
- •History of severe pre-eclampsia or severe gestational hypertension (GHTN), which required medical intervention. Definition according to AWMF guideline (AWMF, 2019)
- •Presence of severe disease impairing course of pregnancy (e.g. diabetes, epilepsy, cancer)
- •Congenital or acquired autoimmune disease
- •Known immunosuppressive (e.g., transplanted patients) or immunodeficient condition
- •Known infection with hepatitis B or C, or HIV from the medical history or active infection at screening as assessed by respective virus serology
- •Maternal CMV infection prior to this pregnancy (preconceptional CMV infection)
- •Covid-19 infection at time of inclusion
- •Any signs or symptoms indicating an increased risk of abortion or premature labor or has known negative effect on fetus with exception of a CMV infection
- •Active infection according to TORCH serology with exception of CMV in the assessment of the investigator
- •Known major fetal anomalies or demise
- •Intolerance to proteins of human origin or known allergic reactions to components of the trial product
- •Selective absolute IgA deficiency or known antibodies to IgA
- •Known pre-existing clinically relevant risk factors for thrombotic events
- •Known renal insufficiency with serum creatinine levels >1.4 mg/dL and proteinuria (albuminuria) at screening (≥30 mg/dL or dipstick reading of 1+ and greater)
- •Participation in another clinical trial within 90 days before entering the trial or during the trial
- •Women who are dependent on trial site staff, on Biotest AG or its authorized representatives
- •Inability or lacking motivation to participate in the trial
- •Medical condition, laboratory finding, or physical examination finding that in the opinion of the investigator precludes participationInability or lacking motivation to participate in the trial
- •Eligibility for a subgroup where enrollment was stopped
研究组 & 干预措施
BT097
Experimental
Subjects will receive BT097 200 U per kg of maternal body weight intravenously every 2 weeks until at least GW 17
干预措施: BT097 (Drug)
结局指标
主要结局
To determine the overall rate of maternal-fetal transmission at the time of amniocentesis (week 20 [-1 week / +2 weeks] of gestation)
时间窗: Gestational week 19 - week 22
To determine the overall rate of maternal-fetal transmission at the time of amniocentesis
次要结局
- To evaluate vitality of the fetuses/newborns(until date of delivery)
- To evaluate the rate of congenital CMV infection at delivery or within the first 3 days after delivery(Date of Delivery + 3 days)
- To measure the number of CMV-DNA copies in the urine of newborns(Date of Delivery)
- Subgroups: (1) Subjects with periconceptionally acquired infection or (2) Subjects with infection acquired during first trimester(Gestational week 20 +-1 Week)
- To determine maternal CMV viral load (copies/ml)(until gestational week 30)
- To determine maternal anti-CMV IgG Levels (U/ml)(until gestational week 30)
- To determine maternal anti-CMV IgG avidity (%)(until gestational week 30)
- To determine maternal anti-CMV IgM index (Index)(until gestational week 30)
- To determine soluble fms-like tyrosine kinase 1 (sFlt-1) concentration in maternal serum(until gestational week 30)
- To evaluate growth of the fetuses/newborns(Until date of delivery)
- To assess the number, severity, causality, outcome, and seriousness of all adverse events (AEs)/ treatment-emergent AEs (TEAEs)/ AEs of special interest until delivery (+3 days) in both mother and fetus/newborn(Date of Delivery + 3 days)
研究者
研究点 (5)
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