Status:
COMPLETED
Efficacy Study of Human Cytomegalovirus (HCMV) Hyperimmune Globulin to Prevent Congenital HCMV Infection
Lead Sponsor:
Fondazione IRCCS Policlinico San Matteo di Pavia
Conditions:
Cytomegalovirus Infection
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The aim of this trial is to verify, under controlled conditions, the reported efficacy of human cytomegalovirus (HCMV)-specific hyperimmune globulin administration to pregnant women suffering from pri...
Detailed Description
HCMV is the leading infectious cause of mental retardation and deafness in infants with congenital HCMV infection. Primary HCMV infections during pregnancy carry the highest risk of fetal infection an...
Eligibility Criteria
Inclusion
- pregnant women (in vitro fertilization permitted)
- \>= 18 years of age
- primary HCMV infection at 5-26 weeks' gestation
- \<= 6 weeks from presumed onset of infection
- gestational age between 5-32 weeks' gestation
- written informed consent
Exclusion
- multiple pregnancy
- history of HIV or HBV or HCV infection
- known immunodeficiency or immunosuppression
- congenital or acquired autoimmune disease
- known intolerance to protein of human origin
- known intolerance to immune globulin
- history of adverse effects to vaccination
- hypersensitivity to human immune globulin (pathological IgG or IgA deficiences)
- renal failure
- serious organic or psychiatric disease
- lack of motivation to participate in the study
- women unable to satisfy study requirements
- women not willing or unable to provide written informed consent
- women not willing to give consent to transmission of anonymised data
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT00881517
Start Date
June 1 2009
End Date
October 1 2011
Last Update
December 8 2011
Active Locations (11)
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1
Dipartimento di Ostetricia e Ginecologia, Ospedali Riuniti
Bergamo, Italy, 24128
2
Medicina dell'Età Prenatale, Ospedale Policlinico S.Orsola
Bologna, Italy, 40138
3
Medicina Materno-Fetale, Spedali Civili
Brescia, Italy, 25123
4
UOC Malattie Infettive, IRCCS Istituto G.Gaslini
Genova, Italy, 16147