Clinical trial NCT05170269: Prevention of Maternal-fetal Cytomegalovirus Transmission After Primary Maternal Infection, GW ≤ 14 (PreCyssion)
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Congenital Cytomegalovirus Infection
Keywords: Cytomegalovirus
Pregnancy
CMVIG
maternal CMV infection
Lead sponsor: Biotest
Sponsor class: INDUSTRY
First posted: 2021-12-27
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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).


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: To determine the overall rate of maternal-fetal transmission at the time of amniocentesis (week 20 [-1 week / +2 weeks] of gestation)
timeFrame: Gestational week 19 - week 22
Secondary outcomes:
measure: Subgroups: (1) Subjects with periconceptionally acquired infection or (2) Subjects with infection acquired during first trimester
timeFrame: Gestational week 20 +-1 Week
measure: To determine maternal CMV viral load (copies/ml)
timeFrame: until gestational week 30
measure: To determine maternal anti-CMV IgG Levels (U/ml)
timeFrame: until gestational week 30
measure: To determine maternal anti-CMV IgG avidity (%)
timeFrame: until gestational week 30
measure: To determine maternal anti-CMV IgM index (Index)
timeFrame: until gestational week 30
measure: To determine soluble fms-like tyrosine kinase 1 (sFlt-1) concentration in maternal serum
timeFrame: until gestational week 30
measure: To evaluate vitality of the fetuses/newborns
timeFrame: until date of delivery
measure: To evaluate growth of the fetuses/newborns
timeFrame: Until date of delivery
measure: To evaluate the rate of congenital CMV infection at delivery or within the first 3 days after delivery
timeFrame: Date of Delivery + 3 days
measure: To measure the number of CMV-DNA copies in the urine of newborns
timeFrame: Date of Delivery
measure: 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
timeFrame: Date of Delivery + 3 days
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: 4906
city: Bonn
country: Germany
facility: 4903
city: Erlangen
country: Germany
facility: 4902
city: Tuebingen
country: Germany
facility: 4901
city: Wasserburg am Inn
country: Germany
facility: 4905
Study officials:
affiliation: Universitätsklinik Tuebingen - Frauenklinik; 72076 Tübingen
name: Karl O Kagan, Prof
role: PRINCIPAL_INVESTIGATOR
References: