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

Cytomegalovirus Infection Clinical Trial

— CHIP  

Official title:

Prevention of Human Cytomegalovirus (HCMV) Mother-to-fetus Transmission by Administration of Virus-specific Hyperimmune Globulin to Pregnant Women With Primary HCMV Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00881517
• Other study ID #: FARM7J4HCH
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 14, 2009
• Last updated: December 7, 2011
• Start date: June 2009
• Est. completion date: October 2011

Study information

• Verified date: December 2011
• Source: IRCCS Policlinico S. Matteo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Communicable Diseases
• Cytomegalovirus Infection
• Cytomegalovirus Infections
• Infection

Intervention

Drug:
• 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.
• 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

Locations

Country	Name	City	State
Italy	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	Milano
Italy	Ostetricia e Ginecologia, Ospedale V.Buzzi	Milano
Italy	Struttura Semplice di Ostetricia, Ospedale Niguarda Cà Granda	Milano
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

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Policlinico S. Matteo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of congenital HCMV infection in the fetus/newborn		At amniocentesis and/or within one week after birth	No
Secondary	HCMV-specific immune response (humoral and cell-mediated)		36-48 months	No
Secondary	Virological and histological findings in placentas		36-48 months	No
Secondary	Clinical outcome of newborns with congenital HCMV infection		within 2 weeks after birth	No
Secondary	Safety of Cytotect in the mother and newborn		within 24 hours after delivery	Yes