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Completed

NCT Number: NCT00881517

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

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Key information

Conditions

Cytomegalovirus Infection Cytomegalovirus Infections DNA Virus Infections Herpesviridae Infections Infections Virus Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Dipartimento di Ostetricia e Ginecologia, Ospedali Riuniti, Bergamo, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HCMV-specific hyperimmune globulin (Cytotect®)

Drug

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

Other names: Cytotect®

Isotonic solution of sodium chloride (placebo)

Drug

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

Primary outcomes

  1. Evidence of congenital HCMV infection in the fetus/newborn

    Time frame: At amniocentesis and/or within one week after birth

Secondary outcomes

  1. HCMV-specific immune response (humoral and cell-mediated)

    Time frame: 36-48 months

  2. Virological and histological findings in placentas

    Time frame: 36-48 months

  3. Clinical outcome of newborns with congenital HCMV infection

    Time frame: within 2 weeks after birth

  4. Safety of Cytotect in the mother and newborn

    Time frame: within 24 hours after delivery

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Registry information

Official study title

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

Acronym: CHIP

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Apr 15, 2009
Registry last updated
Dec 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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