EUCTR2020-002383-32-DE进行中（未招募）1 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 - PreCyssion
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Biotest AG
- 入组人数
- 80
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. 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
- •2. Pregnant women, age 18 to 45 years
- •3. Pregnant women at trial entry with gestational age =14 weeks; pregnancy after in-vitro fertilization permitted
- •4. Detection of early primary CMV infection
- •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 80
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Women with current multiple pregnancy
- •2. History of severe pre-eclampsia or severe gestational hypertension (GHTN), which required medical intervention. Definition according to AWMF guideline (AWMF, 2019)
- •3. Presence of severe disease impairing course of pregnancy (e.g. diabetes, epilepsy, cancer)
- •4. Clinically significant congenital or acquired autoimmune disease
- •5. Known immunosuppressive (e.g., transplanted patients) or immunodeficient condition
- •6. Known infection with hepatitis B or C, or HIV from the medical history or active infection at screening as assessed by respective virus serology
- •7. Maternal CMV infection prior to this pregnancy
- •8. Covid-19 infection at time of inclusion
- •9. 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
- •10. Active infection according to TORCH serology with exception of CMV in the assessment of the investigator
- •11. Known major fetal anomalies or demise
- •12. Intolerance to proteins of human origin or known allergic reactions to components of the trial product
- •13. Selective absolute IgA deficiency or known antibodies to IgA
- •14. Known pre-existing clinically relevant risk factors for thrombotic events
- •15. 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)
- •16. Participation in another clinical trial within 90 days before entering the trial or during the trial
- •17. Women who are dependent on trial site staff, on Biotest AG or its authorized representatives
- •18. Inability or lacking motivation to participate in the trial
- •19. Medical condition, laboratory finding, or physical examination finding that in the opinion of the investigator precludes participation
- •20. Eligibility for a subgroup where enrollment was stopped
研究者
相似试验
进行中（未招募）
1 期
Prevention of congenital cytomegalovirus infection in infants of mothers with primary cytomegalovirus infection during pregnancy. A randomised, open, controlled, multicentre and multinational study investigating efficacy and safety of Cytotect FH, nanometer filtered (BT094)Congenital CMV infection after primary CMV infection during pregnancyMedDRA version: 18.0Level: LLTClassification code 10010420Term: Congenital CMV infectionSystem Organ Class: 100000004850EUCTR2007-004692-19-DEBiotest AG16,000
进行中（未招募）
1 期
Prevention of congenital CMV infection in infants of mothers with primary CMV infection during pregnancyCONGENITAL CMV INFECTION IN NEWBORN FROM MOTHERS WITH PRIMARY CMV INFECTION DURING PREGNANCYMedDRA version: 14.1Level: SOCClassification code 10010331Term: Congenital, familial and genetic disordersSystem Organ Class: 10010331 - Congenital, familial and genetic disordersMedDRA version: 14.1Level: LLTClassification code 10010420Term: Congenital CMV infectionSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2007-004692-19-ITBIOTEST AG25,000
进行中（未招募）
1 期
Prevention of congenital cytomegalovirus infection in infants of mothers with primary cytomegalovirus infection during pregnancy. A randomised, open, controlled, multicentre and multinational study investigating efficacy and safety of Cytotect FH, nanometer filtered (BT094)Congenital CMV infection after primary CMV infection during pregnancyMedDRA version: 17.0Level: LLTClassification code 10010420Term: Congenital CMV infectionSystem Organ Class: 100000004850EUCTR2007-004692-19-HUBiotest AG15,474
进行中（未招募）
1 期
Prevention of congenital cytomegalovirus infection in infants of mothers with primary cytomegalovirus infection during pregnancy. A randomised, open, controlled, multicentre and multinational study investigating efficacy and safety of Cytotect FH, nanometer filtered (BT094)Congenital CMV infection after primary CMV infection during pregnancyMedDRA version: 19.0Level: LLTClassification code 10010420Term: Congenital CMV infectionSystem Organ Class: 100000004850EUCTR2007-004692-19-ATBiotest AG16,000
进行中（未招募）
1 期
Prevention of congenital cytomegalovirus infection in infants of mothers with primary cytomegalovirus infection during pregnancy. A randomised, open, controlled, multicentre and multinational study investigating efficacy and safety of Cytotect FH, nanometer filtered (BT094)EUCTR2007-004692-19-BEBiotest AG16,000