Cytomegalovirus InfectionPhase 2/3CHIPNCT00881517
Efficacy Study of Human Cytomegalovirus (HCMV) Hyperimmune Globulin to Prevent Congenital HCMV Infection
A Phase 2/3 study testing HCMV-specific hyperimmune globulin (Cytotect®) in people with Cytomegalovirus Infection, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 11 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cytomegalovirus Infection
- What is being tested?
- HCMV-specific hyperimmune globulin (Cytotect®)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 11 sitesItaly
- Study dates
- Jun 2009to Oct 2011
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Italy11 sites
Dipartimento di Ostetricia e Ginecologia, Ospedali Riuniti
Bergamo, 24128
Medicina dell'Età Prenatale, Ospedale Policlinico S.Orsola
Bologna, 40138
Medicina Materno-Fetale, Spedali Civili
Brescia, 25123
UOC Malattie Infettive, IRCCS Istituto G.Gaslini
Genova, 16147
Dipartimento per la salute della donna, del bambino e del neonato. Ospedale Maggiore Policlinico Mangiagalli e Regina Elena
Milan, 20122
Ostetricia e Ginecologia, Ospedale V.Buzzi
Milan, 20154
Struttura Semplice di Ostetricia, Ospedale Niguarda Cà Granda
Milan, 20162
Clinica Ostetrica e Ginecologica, Ospedale S. Gerardo
Monza, 20052
Ostetricia e Ginecologia, Fondazione IRCCS Policlinico San Matteo
Pavia, 27100
SCDU Ostetricia e Ginecologia a indirizzo materno fetale, Dipartimento di Discipline Ginecologiche e Ostetriche, Università di Torino
Torino, 10126
Dipartimento di Ostetricia e Ginecologia, IRCCS Burlo Garofolo
Trieste, 34137
About this study
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
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.
Read the 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.
- Conditions
- Cytomegalovirus Infection
- Being tested
- HCMV-specific hyperimmune globulin (Cytotect®), Isotonic solution of sodium chloride (placebo)
- Keywords
- human cytomegalovirus, immune globulin, congenital infection, prevention, pregnancy
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCMV-specific hyperimmune globulin (Cytotect®)Drug
Also called Cytotect®
100U (2.0ml)/Kg i.v. every 4 weeks up to 38 weeks' gestation or HCMV-positive amniocentesis or pregnancy termination.
Isotonic solution of sodium chloride (placebo)Drug
2.0ml/Kg i.v. every 4 weeks until 38 weeks'gestation or HCMV-positive amniocentesis or pregnancy termination
| Study group | Role | What they receive |
|---|---|---|
| Cytotect | Experimental | Not described Receives: Drug: HCMV-specific hyperimmune globulin (Cytotect®) |
| placebo | Placebo comparator | Not described Receives: Drug: Isotonic solution of sodium chloride (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of congenital HCMV infection in the fetus/newborn
Measured: At amniocentesis and/or within one week after birth
Secondary outcomes (4)
HCMV-specific immune response (humoral and cell-mediated)
Measured: 36-48 months
Virological and histological findings in placentas
Measured: 36-48 months
Clinical outcome of newborns with congenital HCMV infection
Measured: within 2 weeks after birth
Safety of Cytotect in the mother and newborn
Measured: within 24 hours after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2009 (estimated)
- Study startJun 2009
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cytomegalovirus InfectionStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Grazia Revello, Fondazione IRCCS Policlinico San Matteo di Pavia
- Investigators
- Maria Grazia Revello, MD, Principal investigator, SC Ostetricia e Ginecologia, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00881517
- Sponsor's protocol ID
- FARM7J4HCH
- Acronym
- CHIP
- Status last verified
- Dec 2011
- First submitted
- 14 Apr 2009
- Last updated
- 8 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 24693891
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00881517
- Acronym / sponsor ID
- CHIP / FARM7J4HCH
- Conditions
- Cytomegalovirus Infection
- Keywords
- human cytomegalovirus, immune globulin, congenital infection, prevention, pregnancy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 15 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cytotect | Experimental | Drug: HCMV-specific hyperimmune globulin (Cytotect®) |
| placebo | Placebo comparator | Drug: Isotonic solution of sodium chloride (placebo) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HCMV-specific hyperimmune globulin (Cytotect®)Also: Cytotect®100U (2.0ml)/Kg i.v. every 4 weeks up to 38 weeks' gestation or HCMV-positive amniocentesis or pregnancy termination. | Drug | Cytotect |
| 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 | Drug | placebo |
Primary outcome
Evidence of congenital HCMV infection in the fetus/newborn
Time frame: At amniocentesis and/or within one week after birth
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2011.
- Derived from this study: PubMed 24693891Revello 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Grazia Revello, MD principal investigator
SC Ostetricia e Ginecologia, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing HCMV-specific hyperimmune globulin (Cytotect®) in people with Cytomegalovirus Infection, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 11 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of congenital HCMV infection in the fetus/newborn (time frame: At amniocentesis and/or within one week after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00881517, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2011.