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

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ClinicalTrials.gov Identifier: NCT00881517
Recruitment Status : Completed
First Posted : April 15, 2009
Last Update Posted : December 8, 2011
Sponsor:
Information provided by (Responsible Party):
Maria Grazia Revello, IRCCS Policlinico S. Matteo

Tracking Information
First Submitted Date  ICMJE April 14, 2009
First Posted Date  ICMJE April 15, 2009
Last Update Posted Date December 8, 2011
Study Start Date  ICMJE June 2009
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 14, 2009)
Evidence of congenital HCMV infection in the fetus/newborn [ Time Frame: At amniocentesis and/or within one week after birth ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2009)
  • HCMV-specific immune response (humoral and cell-mediated) [ Time Frame: 36-48 months ]
  • Virological and histological findings in placentas [ Time Frame: 36-48 months ]
  • Clinical outcome of newborns with congenital HCMV infection [ Time Frame: within 2 weeks after birth ]
  • Safety of Cytotect in the mother and newborn [ Time Frame: within 24 hours after delivery ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy Study of Human Cytomegalovirus (HCMV) Hyperimmune Globulin to Prevent Congenital HCMV Infection
Official Title  ICMJE Prevention of Human Cytomegalovirus (HCMV) Mother-to-fetus Transmission by Administration of Virus-specific Hyperimmune Globulin to Pregnant Women With Primary HCMV Infection
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Cytomegalovirus Infection
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Cytotect
    Intervention: Drug: HCMV-specific hyperimmune globulin (Cytotect®)
  • Placebo Comparator: placebo
    Intervention: Drug: Isotonic solution of sodium chloride (placebo)
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 7, 2011)
124
Original Estimated Enrollment  ICMJE
 (submitted: April 14, 2009)
120
Actual Study Completion Date  ICMJE October 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00881517
Other Study ID Numbers  ICMJE FARM7J4HCH
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Maria Grazia Revello, IRCCS Policlinico S. Matteo
Study Sponsor  ICMJE IRCCS Policlinico S. Matteo
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Maria Grazia Revello, MD SC Ostetricia e Ginecologia, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
PRS Account IRCCS Policlinico S. Matteo
Verification Date December 2011

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