Efficacy Study of Human Cytomegalovirus (HCMV) Hyperimmun... | NCT00881517

Status Module

Record Verification Date

Dec 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Oct 2011Actual

Completion Date

Oct 2011Actual

First Submitted Date

Apr 14, 2009

First Submission Date that Met QC Criteria

Apr 14, 2009

First Posted Date

Apr 15, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 7, 2011

Last Update Posted Date

Dec 8, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Maria Grazia Revello, researcher, Fondazione IRCCS Policlinico San Matteo di PaviaPrincipal Investigator

Lead Sponsor

Fondazione IRCCS Policlinico San Matteo di PaviaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

124Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cytotect	Experimental		Drug: HCMV-specific hyperimmune globulin (Cytotect®)
placebo	Placebo Comparator		Drug: Isotonic solution of sodium chloride (placebo)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.	Cytotect

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evidence of congenital HCMV infection in the fetus/newborn		At amniocentesis and/or within one week after birth

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Maria Grazia Revello, MD	SC Ostetricia e Ginecologia, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dipartimento di Ostetricia e Ginecologia, Ospedali Riuniti		Bergamo		24128	Italy
Medicina dell'Età Prenatale, Ospedale Policlinico S.Orsola

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24693891	Derived	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.

ID	Term
D006566	Herpesviridae Infections
D004266	DNA Virus Infections
D014777	Virus Diseases
D007239	Infections