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

Trial details

Who runs it

Biotest

Trial code

NCT05170269

Record updated

10 March 2025

Original description

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).Read full original descriptionShow less

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

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).

Inclusion: 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: Maternal CMV infection prior to this pregnancy (preconceptional CMV infection); Selective absolute IgA deficiency or known antibodies to IgA; Participation in another clinical trial within 90 days before entering the trial or during the trial; 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; 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; Intolerance to proteins of human origin or known allergic reactions to components of the trial product; 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); 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; Women with current multiple pregnancy; Known major fetal anomalies or demise; Known pre-existing clinically relevant risk factors for thrombotic events; Women who are dependent on trial site staff, on Biotest AG or its authorized representatives; Inability or lacking motivation to participate in the trial; Eligibility for a subgroup where enrollment was stopped.

ClinicalTrials.gov NCT05170269