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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00881517
Recruitment Status : Completed
First Posted : April 15, 2009
Last Update Posted : December 8, 2011
Information provided by (Responsible Party):
Maria Grazia Revello, IRCCS Policlinico S. Matteo

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.

Condition or disease Intervention/treatment Phase
Cytomegalovirus Infection Drug: HCMV-specific hyperimmune globulin (Cytotect®) Drug: Isotonic solution of sodium chloride (placebo) Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Study Start Date : June 2009
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Cytotect

Arm Intervention/treatment
Experimental: Cytotect 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®

Placebo Comparator: placebo 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

Primary Outcome Measures :
  1. Evidence of congenital HCMV infection in the fetus/newborn [ Time Frame: At amniocentesis and/or within one week after birth ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00881517

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Dipartimento di Ostetricia e Ginecologia, Ospedali Riuniti
Bergamo, Italy, 24128
Medicina dell'Età Prenatale, Ospedale Policlinico S.Orsola
Bologna, Italy, 40138
Medicina Materno-Fetale, Spedali Civili
Brescia, Italy, 25123
UOC Malattie Infettive, IRCCS Istituto G.Gaslini
Genova, Italy, 16147
Dipartimento per la salute della donna, del bambino e del neonato. Ospedale Maggiore Policlinico Mangiagalli e Regina Elena
Milano, Italy, 20122
Ostetricia e Ginecologia, Ospedale V.Buzzi
Milano, Italy, 20154
Struttura Semplice di Ostetricia, Ospedale Niguarda Cà Granda
Milano, Italy, 20162
Clinica Ostetrica e Ginecologica, Ospedale S. Gerardo
Monza, Italy, 20052
Ostetricia e Ginecologia, Fondazione IRCCS Policlinico San Matteo
Pavia, Italy, 27100
SCDU Ostetricia e Ginecologia a indirizzo materno fetale, Dipartimento di Discipline Ginecologiche e Ostetriche, Università di Torino
Torino, Italy, 10126
Dipartimento di Ostetricia e Ginecologia, IRCCS Burlo Garofolo
Trieste, Italy, 34137
Sponsors and Collaborators
IRCCS Policlinico S. Matteo
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Principal Investigator: Maria Grazia Revello, MD SC Ostetricia e Ginecologia, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Maria Grazia Revello, researcher, IRCCS Policlinico S. Matteo Identifier: NCT00881517    
Other Study ID Numbers: FARM7J4HCH
First Posted: April 15, 2009    Key Record Dates
Last Update Posted: December 8, 2011
Last Verified: December 2011
Keywords provided by Maria Grazia Revello, IRCCS Policlinico S. Matteo:
human cytomegalovirus
immune globulin
congenital infection
Additional relevant MeSH terms:
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Communicable Diseases
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Immunologic Factors
Physiological Effects of Drugs