Clinical study investigating efficacy and safety of Cytotect CP Biotest in preventing maternal-fetal transmission of cytomegalovirus

Phase 1

• Conditions: Prevention of maternal-fetal cytomegalovirus transmission after primary maternal infection with gestational age = 14 weeks; MedDRA version: 21.0Level: PTClassification code 10010430Term: Congenital cytomegalovirus infectionSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; MedDRA version: 20.0Level: LLTClassification code 10036654Term: PreventionSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-002383-32-DE
• Lead Sponsor: Biotest AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-01
• Last Update Posted: 11 September 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

1. 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
2. Pregnant women, age 18 to 45 years
3. Pregnant women at trial entry with gestational age =14 weeks; pregnancy after in-vitro fertilization permitted
4. Detection of early primary CMV infection

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Women with current multiple pregnancy
2. History of severe pre-eclampsia or severe gestational hypertension (GHTN), which required medical intervention. Definition according to AWMF guideline (AWMF, 2019)
3. Presence of severe disease impairing course of pregnancy (e.g. diabetes, epilepsy, cancer)
4. Clinically significant congenital or acquired autoimmune disease
5. Known immunosuppressive (e.g., transplanted patients) or immunodeficient condition
6. Known infection with hepatitis B or C, or HIV from the medical history or active infection at screening as assessed by respective virus serology
7. Maternal CMV infection prior to this pregnancy
8. Covid-19 infection at time of inclusion
9. 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
10. Active infection according to TORCH serology with exception of CMV in the assessment of the investigator
11. Known major fetal anomalies or demise
12. Intolerance to proteins of human origin or known allergic reactions to components of the trial product
13. Selective absolute IgA deficiency or known antibodies to IgA
14. Known pre-existing clinically relevant risk factors for thrombotic events
15. 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)
16. Participation in another clinical trial within 90 days before entering the trial or during the trial
17. Women who are dependent on trial site staff, on Biotest AG or its authorized representatives
18. Inability or lacking motivation to participate in the trial
19. Medical condition, laboratory finding, or physical examination finding that in the opinion of the investigator precludes participation
20. Eligibility for a subgroup where enrollment was stopped

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified