Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-24 @ 10:58 PM
NCT ID:
NCT05170269
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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT05170269
Study Brief:
Protocol Section:
NCT05170269