Prevention of congenital CMV infection in infants of mothers with primary CMV infection during pregnancy

Phase 1

• Conditions: CONGENITAL CMV INFECTION IN NEWBORN FROM MOTHERS WITH PRIMARY CMV INFECTION DURING PREGNANCY; MedDRA version: 14.1Level: LLTClassification code 10010420Term: Congenital CMV infectionSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; MedDRA version: 14.1Level: SOCClassification code 10010331Term: Congenital, familial and genetic disordersSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2007-004692-19-IT
• Lead Sponsor: BIOTEST AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-26
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 25000

Inclusion Criteria

1. OREGNANT WOMAN, PREGNANCY AFTER IN VITRO FERTILISATION PERMITTED 2. CMV-SPECIFIC IgG seronegative pregnant women at study entry 3. 18 to 45 years of age 4. consent to carrying out a histopatological analysis of foetal brain, liver and pleen biopsy specimen in case of pregnancy termination or spontaneous abortion after confirmed serconversion during pregnancy.
Are the trial subjects under 18? yes
Number of subjects for this age range: 100000
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

1. women with multigravidity 2. women who are planning a home birth 3. known immunodeficiency or immunosuppression 4. known hepatitis Bor C infections 5. known intolerance to proteins of human origin 6.known intolerance to immunoglobulins or comparable substances 7. known or suspected deficiency of immunoglobulin A 8. known HIV infection 9. Known hypersensivity and/or idiosyncrasy to any of the test compounds or excipients amployed.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: OREVENTION 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 PARAMETER.;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 confrimed 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: duration for the individual pregnant woman depens on CMV serology status, timepoint of inclusion and timepoint of possible CMV seroconversion (about 1 day - 9 months)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): mother: CMV igG serum level (recombinant blot with avidity/ antiHCMV rec. gB igG ELISA); Foetus: ultrasound abnormalities (EFSUMB level II/III); newborn: clinical symptoms parameters( feature/number/severity of abnormalities and clinically relevant laboratory findings);Timepoint(s) of evaluation of this end point: from 1 day to 9 months