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

997

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).

2021-11-17

2023-12-31

2024-08-31

Active (not recruiting)

Early phase I

80

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}

2023-10-23