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

Biotest

Status and phase

Active, not recruiting

Phase 3

Conditions

Congenital Cytomegalovirus Infection

Treatments

Drug: BT097

Study type

Interventional

Funder types

Industry

Identifiers

NCT05170269

2020-002383-32 (EudraCT Number)

997

Details and patient eligibility

About

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).

Enrollment

80 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No 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
Eligibility for a subgroup where enrollment was stopped