Efficacy Study of Human Cytomegalovirus (HCMV) Hyperimmune Globulin to Prevent Congenital HCMV Infection

NCT ID: NCT00881517

Last Updated: 2011-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2011-10-31

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 primary HCMV infection for the prevention of intrauterine HCMV transmission.

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 and disease. No intervention of proven efficacy is available in case of primary HCMV infection in pregnancy. However, a study published in 2005 (Nigro et al., NEJM 353:1350-62, 2005) reported that in pregnant women with primary HCMV infection treated with HCMV-specific hyperimmune globulin (Cytotect®, Biotest) the risk of transmitting the infection to the fetus was reduced from 40% to 16%. Unfortunately, since the study was conducted with inadequate controls, the actual efficacy of hyperimmune globulin could not be properly assessed.

In the present randomized, double-blind, placebo-controlled, multicenter trial pregnant women with ascertained primary HCMV infection at 4-26 weeks of gestation will be randomized to receive Cytotect® or placebo intravenously within 6 weeks after the presumed onset of infection.

Primary efficacy parameter will be the number of HCMV-infected newborns or fetuses.

Conditions

Cytomegalovirus Infection

Keywords

human cytomegalovirus; immune globulin; congenital infection; prevention; pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Cytotect

Group Type: EXPERIMENTAL

HCMV-specific hyperimmune globulin (Cytotect®)

Intervention Type: DRUG

100U (2.0ml)/Kg i.v. every 4 weeks up to 38 weeks' gestation or HCMV-positive amniocentesis or pregnancy termination.

placebo

Group Type: PLACEBO_COMPARATOR

Isotonic solution of sodium chloride (placebo)

Intervention Type: DRUG

2.0ml/Kg i.v. every 4 weeks until 38 weeks'gestation or HCMV-positive amniocentesis or pregnancy termination

Interventions

HCMV-specific hyperimmune globulin (Cytotect®)

100U (2.0ml)/Kg i.v. every 4 weeks up to 38 weeks' gestation or HCMV-positive amniocentesis or pregnancy termination.

Intervention Type: DRUG

Isotonic solution of sodium chloride (placebo)

2.0ml/Kg i.v. every 4 weeks until 38 weeks'gestation or HCMV-positive amniocentesis or pregnancy termination

Intervention Type: DRUG

Other Intervention Names

Cytotect®

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fondazione IRCCS Policlinico San Matteo di Pavia

OTHER

Sponsor Role: lead

Responsible Party

Maria Grazia Revello

researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maria Grazia Revello, MD

Role: PRINCIPAL_INVESTIGATOR

SC Ostetricia e Ginecologia, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy

Locations

Dipartimento di Ostetricia e Ginecologia, Ospedali Riuniti

Bergamo, , Italy

Medicina dell'Età Prenatale, Ospedale Policlinico S.Orsola

Bologna, , Italy

Medicina Materno-Fetale, Spedali Civili

Brescia, , Italy

UOC Malattie Infettive, IRCCS Istituto G.Gaslini

Genova, , Italy

Dipartimento per la salute della donna, del bambino e del neonato. Ospedale Maggiore Policlinico Mangiagalli e Regina Elena

Milan, , Italy

Ostetricia e Ginecologia, Ospedale V.Buzzi

Milan, , Italy

Struttura Semplice di Ostetricia, Ospedale Niguarda Cà Granda

Milan, , Italy

Clinica Ostetrica e Ginecologica, Ospedale S. Gerardo

Monza, , Italy

Ostetricia e Ginecologia, Fondazione IRCCS Policlinico San Matteo

Pavia, , Italy

SCDU Ostetricia e Ginecologia a indirizzo materno fetale, Dipartimento di Discipline Ginecologiche e Ostetriche, Università di Torino

Torino, , Italy

Dipartimento di Ostetricia e Ginecologia, IRCCS Burlo Garofolo

Trieste, , Italy

Countries

Italy

References

Revello MG, Lazzarotto T, Guerra B, Spinillo A, Ferrazzi E, Kustermann A, Guaschino S, Vergani P, Todros T, Frusca T, Arossa A, Furione M, Rognoni V, Rizzo N, Gabrielli L, Klersy C, Gerna G; CHIP Study Group. A randomized trial of hyperimmune globulin to prevent congenital cytomegalovirus. N Engl J Med. 2014 Apr 3;370(14):1316-26. doi: 10.1056/NEJMoa1310214.

Reference Type: DERIVED

PMID: 24693891 (View on PubMed)

Other Identifiers

FARM7J4HCH

Identifier Type: -

Identifier Source: org_study_id