Congenital CMV infection after primary CMV infection during pregnancy MedDRA version: 18.0 Level: LLT Classification code 10010420 Term: Congenital CMV infection System Organ Class: 100000004850
Conditions
Interventions
Product Name: Cytotect FH, nanometer filtered
Product Code: BT094
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Human cytomegalovirus immunoglobulin
Other descriptive name: HUMAN NOR
Sponsors
Biotest AG
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Prevention of congenital CMV infection in infants of mothers with primary CMV infection during pregnancy. The number (percentage) of newborns/foetuses with congenital CMV infection is defined as the primary efficacy paramter.;Secondary Objective: As most important secondary efficacy endpoints CMV specific IgG serum concentration in maternal blood, ultrasound abnormalities of the foetus and CMV-related clinical symptoms in the infant will be evaluated.;Primary end point(s): Number of CMV infected newborns/foetuses at birth from seroconverted mothers as confirmed by CMV-DNA using PCR in urinanalysis within 7 days after birth or (additionally) CMV-DNA using PCR of amniotic fluid.;Timepoint(s) of evaluation of this end point: n.a. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Mother: CMV IgG serum level (recombinant blot with avidity / anti-HCMV rec. gB IgG ELISA) Foetus: ultrasound abnormalities (EFSUMB level II/III) Newborn: CMV-related clinical symptoms (feature/number/severity of abnormalities and clinically relevant laboratory findings) ;Timepoint(s) of evaluation of this end point: n.a. | — |
Countries
Austria, Belgium, Germany, Hungary, Italy
Contacts
Public ContactProject Manager Oliver Mauric
J&P MEDICAL RESEARCH LTD.
Outcome results
None listed