Prevention of maternal-fetal cytomegalovirus transmission after primary maternal infection with gestational age = 14 weeks MedDRA version: 21.0 Level: PT Classification code 10010430 Term: Congenital cytomegalovirus infection System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0 Level: LLT Classification code 10036654 Term: Prevention System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Cytotect CP Biotest 100 U/mL solution for infusion
Pharmaceutical Form: Solution for infusion
Sponsors
Biotest AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main purpose of the trial is to demonstrate efficacy and safety of Cytotect CP Biotest in preventing maternal-fetal transmission of cytomegalovirus (CMV). Primary Objective • To determine the overall rate of maternal-fetal transmission at the time of amniocentesis (week 20 [-1 week / +2 weeks] of gestation) ;Secondary Objective: Efficacy: • To determine the rate of maternal-fetal transmission at the time of amniocentesis (week 20 [-1 week / +2 weeks] of gestation) in the 2 subgroups: o Subjects with periconceptionally acquired infection o Subjects with infection acquired during first trimester • To measure maternal CMV viral load, anti-CMV IgG Levels, anti-CMV IgG avidity, anti-CMV IgM index • To determine soluble fms-like tyrosine kinase 1 (sFlt-1) concentration in maternal serum • To evaluate vitality and growth of the fetuses/newborns •To evaluate the rate of congenital CMV infection at delivery or within the first 3 days after delivery • To measure the number of CMV-DNA copies in the urine of newborns Safety: Trial Subject • 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 ;Primary end point(s): The primary endpoint is the overall rate of maternal-fetal transmission at the time of amniocentesis.;Timepoint(s) of evaluation of this end point: At week 20 [- 1 week / +2 weeks] of gestation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Maternal-fetal CMV transmission in the subgroups • CMV viral load (CMV DNA copies/mL) in maternal blood • Anti-CMV IgG levels • Anti-CMV IgG avidity • Detection of CMV IgG and IgM antibodies • Soluble fms-like tyrosine kinase 1 (sFlt-1) / Placental Growth Factor (PlGF) • Vitality, growth and heart rate of the fetus and Apgar-score, head circumference at delivery • CMV-DNA at delivery or within the first 3 days in urine of the newborn;Timepoint(s) of evaluation of this end point: During pregnancy, at week 20 [- 1 week / +2 weeks] of gestation and at delivery | — |
Countries
Germany
Contacts
Public ContactCorporate Clinical Research
Biotest AG
Outcome results
None listed