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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Maria Grazia Revello, IRCCS Policlinico S. Matteo
ClinicalTrials.gov Identifier:
NCT00881517
First received: April 14, 2009
Last updated: December 7, 2011
Last verified: December 2011

April 14, 2009
December 7, 2011
June 2009
October 2011   (final data collection date for primary outcome measure)
Evidence of congenital HCMV infection in the fetus/newborn [ Time Frame: At amniocentesis and/or within one week after birth ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00881517 on ClinicalTrials.gov Archive Site
  • HCMV-specific immune response (humoral and cell-mediated) [ Time Frame: 36-48 months ] [ Designated as safety issue: No ]
  • Virological and histological findings in placentas [ Time Frame: 36-48 months ] [ Designated as safety issue: No ]
  • Clinical outcome of newborns with congenital HCMV infection [ Time Frame: within 2 weeks after birth ] [ Designated as safety issue: No ]
  • Safety of Cytotect in the mother and newborn [ Time Frame: within 24 hours after delivery ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Efficacy Study of Human Cytomegalovirus (HCMV) Hyperimmune Globulin to Prevent Congenital HCMV Infection
Prevention of Human Cytomegalovirus (HCMV) Mother-to-fetus Transmission by Administration of Virus-specific Hyperimmune Globulin to Pregnant Women With Primary HCMV Infection

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Cytomegalovirus Infection
  • 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.
    Other Name: Cytotect®
  • 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
  • Experimental: Cytotect
    Intervention: Drug: HCMV-specific hyperimmune globulin (Cytotect®)
  • Placebo Comparator: placebo
    Intervention: Drug: Isotonic solution of sodium chloride (placebo)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
124
October 2011
October 2011   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00881517
FARM7J4HCH
No
Maria Grazia Revello, IRCCS Policlinico S. Matteo
IRCCS Policlinico S. Matteo
Not Provided
Principal Investigator: Maria Grazia Revello, MD SC Ostetricia e Ginecologia, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
IRCCS Policlinico S. Matteo
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP