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
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by IRCCS Policlinico S. Matteo:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 124
Study Start Date: June 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00881517

Locations
Italy
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
Investigators
Principal Investigator: Maria Grazia Revello, MD SC Ostetricia e Ginecologia, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
  More Information

No publications provided by IRCCS Policlinico S. Matteo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Maria Grazia Revello, researcher, IRCCS Policlinico S. Matteo
ClinicalTrials.gov Identifier: NCT00881517     History of Changes
Other Study ID Numbers: FARM7J4HCH
Study First Received: April 14, 2009
Last Updated: December 7, 2011
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by IRCCS Policlinico S. Matteo:
human cytomegalovirus
immune globulin
congenital infection
prevention
pregnancy

Additional relevant MeSH terms:
Communicable Diseases
Cytomegalovirus Infections
Infection
DNA Virus Infections
Herpesviridae Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 29, 2014