Prevention of Maternal-fetal Cytomegalovirus Transmission After Primary Maternal Infection, GW ≤ 14 (PreCyssion)
- Conditions
- Congenital Cytomegalovirus Infection
- Interventions
- Drug: BT097
- Registration Number
- NCT05170269
- Lead Sponsor
- Biotest
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 80
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BT097 BT097 Subjects will receive BT097 200 U per kg of maternal body weight intravenously every 2 weeks until at least GW 17
- Primary Outcome Measures
Name Time Method To determine the overall rate of maternal-fetal transmission at the time of amniocentesis (week 20 [-1 week / +2 weeks] of gestation) Gestational week 19 - week 22 To determine the overall rate of maternal-fetal transmission at the time of amniocentesis
- Secondary Outcome Measures
Name Time Method To evaluate vitality of the fetuses/newborns until date of delivery Number/percentage of subjects with Normal / Abnormal Not Clinically Significant / Abnormal Clinically Significant results per parameter and visit
To evaluate the rate of congenital CMV infection at delivery or within the first 3 days after delivery Date of Delivery + 3 days 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 Date of Delivery To measure the number of CMV-DNA copies in the urine of newborns
Subgroups: (1) Subjects with periconceptionally acquired infection or (2) Subjects with infection acquired during first trimester Gestational week 20 +-1 Week To determine the rate of maternal-fetal transmission at the time of amniocentesis
To determine maternal CMV viral load (copies/ml) until gestational week 30 Number of CMV-DNA copies (copies/mL) and corresponding absolute and percentage changes from baseline, until gestational week (GW) 30
To determine maternal anti-CMV IgG Levels (U/ml) until gestational week 30 Maternal anti-CMV IgG Levels (U/ml), absolute and percentage changes from baseline
To determine maternal anti-CMV IgG avidity (%) until gestational week 30 Number/percentage of subjects with Low, Intermediate, High avidity
To determine maternal anti-CMV IgM index (Index) until gestational week 30 Number/percentage of subjects with non-reactive, indeterminate and reactive cut-off index (COI)
To determine soluble fms-like tyrosine kinase 1 (sFlt-1) concentration in maternal serum until gestational week 30 Number/percentage of subjects with high (≥1504 pg/mL) or low (\<1504 pg/mL) values
To evaluate growth of the fetuses/newborns Until date of delivery Number/percentage of subjects with Normal / Abnormal Not Clinically Significant / Abnormal Clinically Significant results per parameter and visit
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 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
Trial Locations
- Locations (5)
4902
🇩🇪Erlangen, Germany
4903
🇩🇪Bonn, Germany
4906
🇩🇪Berlin, Germany
4901
🇩🇪Tuebingen, Germany
4905
🇩🇪Wasserburg am Inn, Germany