Efficacy Study of Human Cytomegalovirus (HCMV) Hyperimmune Globulin to Prevent Congenital HCMV Infection
CHIP
Prevention of Human Cytomegalovirus (HCMV) Mother-to-fetus Transmission by Administration of Virus-specific Hyperimmune Globulin to Pregnant Women With Primary HCMV Infection
1 other identifier
interventional
124
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2009
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 14, 2009
CompletedFirst Posted
Study publicly available on registry
April 15, 2009
CompletedStudy Start
First participant enrolled
June 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedDecember 8, 2011
December 1, 2011
2.3 years
April 14, 2009
December 7, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evidence of congenital HCMV infection in the fetus/newborn
At amniocentesis and/or within one week after birth
Secondary Outcomes (4)
HCMV-specific immune response (humoral and cell-mediated)
36-48 months
Virological and histological findings in placentas
36-48 months
Clinical outcome of newborns with congenital HCMV infection
within 2 weeks after birth
Safety of Cytotect in the mother and newborn
within 24 hours after delivery
Study Arms (2)
Cytotect
EXPERIMENTALplacebo
PLACEBO COMPARATORInterventions
100U (2.0ml)/Kg i.v. every 4 weeks up to 38 weeks' gestation or HCMV-positive amniocentesis or pregnancy termination.
2.0ml/Kg i.v. every 4 weeks until 38 weeks'gestation or HCMV-positive amniocentesis or pregnancy termination
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Dipartimento di Ostetricia e Ginecologia, Ospedali Riuniti
Bergamo, 24128, Italy
Medicina dell'Età Prenatale, Ospedale Policlinico S.Orsola
Bologna, 40138, Italy
Medicina Materno-Fetale, Spedali Civili
Brescia, 25123, Italy
UOC Malattie Infettive, IRCCS Istituto G.Gaslini
Genova, 16147, Italy
Dipartimento per la salute della donna, del bambino e del neonato. Ospedale Maggiore Policlinico Mangiagalli e Regina Elena
Milan, 20122, Italy
Ostetricia e Ginecologia, Ospedale V.Buzzi
Milan, 20154, Italy
Struttura Semplice di Ostetricia, Ospedale Niguarda Cà Granda
Milan, 20162, Italy
Clinica Ostetrica e Ginecologica, Ospedale S. Gerardo
Monza, 20052, Italy
Ostetricia e Ginecologia, Fondazione IRCCS Policlinico San Matteo
Pavia, 27100, Italy
SCDU Ostetricia e Ginecologia a indirizzo materno fetale, Dipartimento di Discipline Ginecologiche e Ostetriche, Università di Torino
Torino, 10126, Italy
Dipartimento di Ostetricia e Ginecologia, IRCCS Burlo Garofolo
Trieste, 34137, Italy
Related Publications (1)
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.
PMID: 24693891DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maria Grazia Revello, MD
SC Ostetricia e Ginecologia, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- researcher
Study Record Dates
First Submitted
April 14, 2009
First Posted
April 15, 2009
Study Start
June 1, 2009
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
December 8, 2011
Record last verified: 2011-12