Congenital Cytomegalovirus InfectionPhase 2/3NCT02351102
Valacyclovir to Prevent Vertical Transmission of Cytomegalovirus After Maternal Primary Infection During Pregnancy
A Phase 2/3 study testing Valacyclovir in people with Congenital Cytomegalovirus Infection, run by Rabin Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to determine whether Valacyclovir treatment, administered during pregnancy after proven primary maternal Cytomegalovirus (CMV) infection, reduces fetal transmission rates and prevents fetal injury in cases of fetal infection. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Congenital Cytomegalovirus Infection
- What is being tested?
- Valacyclovir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2015to Jul 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant women over 18 years of age with serologically proven, primary CMV infection during the first trimester of pregnancy or periconceptionally
Who cannot join
- Patients with preexisting liver disease, renal dysfunction, bone marrow suppression or sensitivity to Acyclovir will be excluded from the study - as will patients receiving any antiviral therapy prior to the study.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether Valacyclovir treatment, administered during pregnancy after proven primary maternal Cytomegalovirus (CMV) infection, reduces fetal transmission rates and prevents fetal injury in cases of fetal infection.
Read the detailed description
A randomized, double-blind, placebo-controlled study.
Participants: Pregnant women over 18 years of age with serologically proven, primary CMV infection during the first trimester
Intervention: After informed consent and randomization, participants in the treatment group will receive Valacyclovir at a dose of 8 g/d. Participants in the control group will receive the same amount of daily pills containing placebo. Treatment will continue until amniocentesis, which will determine if the fetus was infected.
- Conditions
- Congenital Cytomegalovirus Infection
- Being tested
- Valacyclovir, Placebo
- Keywords
- Congenital CMV, Congenital Cytomegalovirus
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValacyclovirDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Valacyclovir | Active comparator | Participants will receive Valacyclovir at a dose of 8g/d starting at time of proof of primary maternal CMV infection and until amniocentesis (minimum 21 weeks gestation) Receives: Drug: Valacyclovir |
| Placebo | Placebo comparator | Participants will receive placebo pills (same daily amount as the intervention group) starting at time of proof of primary maternal CMV infection and until amniocentesis (minimum 21 weeks gestation) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
CMV Polymerase Chain Reaction (PCR) in amniotic fluid
amniocentesis will be performed no earlier than 21 weeks gestation, and at least 7 weeks after estimated seroconversion occured. Therefore, the time frame for amniocentesis is estimated between 21 weeks gestation to 28 weeks gestation
Measured: minimum 21 weeks gestation
Secondary outcomes (1)
Clinical evidence of symptomatic congenital CMV infection
laboratory, sonographic or clinical evidence of symptomatic CMV infection present after birth
Measured: within 1 week after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2015 (estimated)
- Study startNov 2015
- Primary completionJul 2019
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Congenital Cytomegalovirus InfectionStudies of the same condition, open and under way.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keren shahar-nissan, Rabin Medical Center
- Investigators
- Keren Shahar-Nissan, Dr, Principal investigator, Schneider Children's Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02351102
- Sponsor's protocol ID
- 655-14
- Status last verified
- Jul 2019
- First submitted
- 18 Jan 2015
- Last updated
- 16 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Buonsenso D, Serranti D, Gargiullo L, Ceccarelli M, Ranno O, Valentini P. Congenital cytomegalovirus infection: current strategies and future perspectives. Eur Rev Med Pharmacol Sci. 2012 Jul;16(7):919-35.
PubMed 22953641Gaytant MA, Steegers EA, Semmekrot BA, Merkus HM, Galama JM. Congenital cytomegalovirus infection: review of the epidemiology and outcome. Obstet Gynecol Surv. 2002 Apr;57(4):245-56. doi: 10.1097/00006254-200204000-00024.
PubMed 11961482Ornoy A, Diav-Citrin O. Fetal effects of primary and secondary cytomegalovirus infection in pregnancy. Reprod Toxicol. 2006 May;21(4):399-409. doi: 10.1016/j.reprotox.2005.02.002.
PubMed 16580941Bodeus M, Kabamba-Mukadi B, Zech F, Hubinont C, Bernard P, Goubau P. Human cytomegalovirus in utero transmission: follow-up of 524 maternal seroconversions. J Clin Virol. 2010 Feb;47(2):201-2. doi: 10.1016/j.jcv.2009.11.009. Epub 2009 Dec 16. No abstract available.
PubMed 20006542Jacquemard F, Yamamoto M, Costa JM, Romand S, Jaqz-Aigrain E, Dejean A, Daffos F, Ville Y. Maternal administration of valaciclovir in symptomatic intrauterine cytomegalovirus infection. BJOG. 2007 Sep;114(9):1113-21. doi: 10.1111/j.1471-0528.2007.01308.x. Epub 2007 Jul 6.
PubMed 17617198Shahar-Nissan K, Pardo J, Peled O, Krause I, Bilavsky E, Wiznitzer A, Hadar E, Amir J. Valaciclovir to prevent vertical transmission of cytomegalovirus after maternal primary infection during pregnancy: a randomised, double-blind, placebo-controlled trial. Lancet. 2020 Sep 12;396(10253):779-785. doi: 10.1016/S0140-6736(20)31868-7.
PubMed 32919517
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Valacyclovir to Prevent Vertical Transmission of Cytomegalovirus After Maternal Primary Infection During Pregnancy
- ClinicalTrials.gov ID
- NCT02351102
- Acronym / sponsor ID
- 655-14
- Conditions
- Congenital Cytomegalovirus Infection
- Keywords
- Congenital CMV, Congenital Cytomegalovirus
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 30 Jan 2015 (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 purpose of this study is to determine whether Valacyclovir treatment, administered during pregnancy after proven primary maternal Cytomegalovirus (CMV) infection, reduces fetal transmission rates and prevents fetal injury in cases of fetal infection.
Detailed description
A randomized, double-blind, placebo-controlled study.
Participants: Pregnant women over 18 years of age with serologically proven, primary CMV infection during the first trimester
Intervention: After informed consent and randomization, participants in the treatment group will receive Valacyclovir at a dose of 8 g/d. Participants in the control group will receive the same amount of daily pills containing placebo. Treatment will continue until amniocentesis, which will determine if the fetus was infected.
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 |
|---|---|---|
| Valacyclovir | Active comparator | Drug: ValacyclovirParticipants will receive Valacyclovir at a dose of 8g/d starting at time of proof of primary maternal CMV infection and until amniocentesis (minimum 21 weeks gestation) |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo pills (same daily amount as the intervention group) starting at time of proof of primary maternal CMV infection and until amniocentesis (minimum 21 weeks gestation) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pregnant women over 18 years of age with serologically proven, primary CMV infection during the first trimester of pregnancy or periconceptionally
Key exclusion criteria (1 listed)
- Patients with preexisting liver disease, renal dysfunction, bone marrow suppression or sensitivity to Acyclovir will be excluded from the study - as will patients receiving any antiviral therapy prior to the study.
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 |
|---|---|---|
| Valacyclovir | Drug | Valacyclovir |
| Placebo | Drug | Placebo |
Primary outcome
CMV Polymerase Chain Reaction (PCR) in amniotic fluid
Time frame: minimum 21 weeks gestation
amniocentesis will be performed no earlier than 21 weeks gestation, and at least 7 weeks after estimated seroconversion occured. Therefore, the time frame for amniocentesis is estimated between 21 weeks gestation to 28 weeks gestation
1 secondary outcome
Clinical evidence of symptomatic congenital CMV infection
Time frame: within 1 week 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 16 Jul 2019.
- Background: PubMed 22953641Buonsenso D, Serranti D, Gargiullo L, Ceccarelli M, Ranno O, Valentini P. Congenital cytomegalovirus infection: current strategies and future perspectives. Eur Rev Med Pharmacol Sci. 2012 Jul;16(7):919-35.
- Background: PubMed 11961482Gaytant MA, Steegers EA, Semmekrot BA, Merkus HM, Galama JM. Congenital cytomegalovirus infection: review of the epidemiology and outcome. Obstet Gynecol Surv. 2002 Apr;57(4):245-56. doi: 10.1097/00006254-200204000-00024.
- Background: PubMed 16580941Ornoy A, Diav-Citrin O. Fetal effects of primary and secondary cytomegalovirus infection in pregnancy. Reprod Toxicol. 2006 May;21(4):399-409. doi: 10.1016/j.reprotox.2005.02.002.
- Background: PubMed 20006542Bodeus M, Kabamba-Mukadi B, Zech F, Hubinont C, Bernard P, Goubau P. Human cytomegalovirus in utero transmission: follow-up of 524 maternal seroconversions. J Clin Virol. 2010 Feb;47(2):201-2. doi: 10.1016/j.jcv.2009.11.009. Epub 2009 Dec 16. No abstract available.
- Results publication: PubMed 17617198Jacquemard F, Yamamoto M, Costa JM, Romand S, Jaqz-Aigrain E, Dejean A, Daffos F, Ville Y. Maternal administration of valaciclovir in symptomatic intrauterine cytomegalovirus infection. BJOG. 2007 Sep;114(9):1113-21. doi: 10.1111/j.1471-0528.2007.01308.x. Epub 2007 Jul 6.
- Derived from this study: PubMed 32919517Shahar-Nissan K, Pardo J, Peled O, Krause I, Bilavsky E, Wiznitzer A, Hadar E, Amir J. Valaciclovir to prevent vertical transmission of cytomegalovirus after maternal primary infection during pregnancy: a randomised, double-blind, placebo-controlled trial. Lancet. 2020 Sep 12;396(10253):779-785. doi: 10.1016/S0140-6736(20)31868-7.
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Cytomegalovirus Infection
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.
Keren Shahar-Nissan, Dr principal investigator
Schneider Children's Medical Center, Israel
1 site 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 Valacyclovir in people with Congenital Cytomegalovirus Infection, run by Rabin Medical Center at 1 site in Israel.
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 1 inclusion and 1 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 16 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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?
CMV Polymerase Chain Reaction (PCR) in amniotic fluid (time frame: minimum 21 weeks gestation). 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 NCT02351102, which also lists 6 linked publications.
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 16 Jul 2019.