Prevention of congenital cytomegalovirus infection in infants of mothers with primary cytomegalovirus infection during pregnancy. A randomised, open, controlled, multicentre and multinational study investigating efficacy and safety of Cytotect FH, nanometer filtered (BT094)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 16000

Inclusion Criteria

- Pregnant women, pregnancy after in-vitro fertilisation permitted
- CMV-specific IgG seronegative pregnant women at screening
- 18 to 45 years of age
- Consent to carrying out a histopathological analysis of foetal brain, liver and kidney biopsy specimen in case of pregnancy termination or spontaneous abortion after confirmed seroconversion during pregnancy
- Written informed consent
Are the trial subjects under 18? yes
Number of subjects for this age range: 98
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25000
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- women with current multiple pregnancy
- women who are planning a home birth
- known immunodeficiency (e.g. congenital agammaglobulinaemia or hypo-gamma-globulinaemia, common variable immunodeficiency, severe combined immuno-deficiencies, Wiskott Aldrich syndrome) or immunosuppression (e.g. renal transplanted patients)
- known hepatitis B or C infections
- known intolerance to proteins of human origin
- known intolerance to immunoglobulins or comparable substances (e.g. vaccination reaction)
- Known hypersensitivity to homologous immunoglobulins, especially very rare cases of IgA deficiency, when the patient has antibodies against IgA
- known HIV infection
- Known pre-existing risk factors for thrombotic events (e.g. history of vascular disease or thrombotic episodes, women with acquired or inherited thrombophilic disorders, severely hypovolemic women or women with diseases which increase blood viscosity)
- Known renal insufficiency
- Known hypersensitivity and/or idiosyncrasy to any of the test compounds or excipients employed
- Participation in another clinical trial within 90 days before entering the study or during the study and/or previous participation in this study during the same pregnancy
- Inability or lack of motivation to participate in the study
- Pregnant women who are unable to comply with the requirements of the study or who in the opinion of the investigator should not participate in the study
- Not willing or able to provide written informed consent to participation in the study after being informed by the investigator about the aim, course and possible risks of the study
- Not willing to give consent to transmission of personal pseudonymised” data to the competent authorities
- Women who are dependant on study site staff, on Biotest AG or its authorised representatives

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials