Prevention of Maternal-fetal Cytomegalovirus Transmission After Primary Maternal Infection, GW ≤ 14 (PreCyssion)

Sponsor

Biotest (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05170269

Collaborator

(none)

Enrollment

Locations

Arm

33.4

Anticipated Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Congenital Cytomegalovirus Infection	Drug: BT097	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Nov 17, 2021

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Aug 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BT097 Subjects will receive BT097 200 U per kg of maternal body weight intravenously every 2 weeks until at least GW 17	Drug: BT097 Subjects will receive BT097 200 U per kg of maternal body weight intravenously every 2 weeks until at least GW 17 Other Names: Cytotect CP Biotest 100 U/mL solution for infusion

Arm

Intervention/Treatment

Experimental: BT097

Subjects will receive BT097 200 U per kg of maternal body weight intravenously every 2 weeks until at least GW 17

Drug: BT097

Subjects will receive BT097 200 U per kg of maternal body weight intravenously every 2 weeks until at least GW 17

Other Names:

Cytotect CP Biotest 100 U/mL solution for infusion

Outcome Measures

Primary Outcome Measures

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

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 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 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 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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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