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NCT01376778 · ClinicalTrials.gov registry record · Phase 3
A Randomized Trial to Prevent Congenital Cytomegalovirus (CMV)
A Phase 3 study, sponsored by The George Washington University Biostatistics Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 399
- Enrollment target
NCT01376778: Completed Phase 3 study, sponsored by The George Washington University Biostatistics Center.
NCT01376778 is a Phase 3 study that has completed, run by The George Washington University Biostatistics Center. The registered enrollment target is 399 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01376778, a Phase 3 study, has completed, sponsored by The George Washington University Biostatistics Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 399 participants
- Enrollment target
Study Summary
Cytomegalovirus (CMV) is a common virus that usually presents with few if any side effects. When first infected, some people may have symptoms similar to mononucleosis (i.e., fatigue, weakness, fever, swollen glands). Most people in the United States are infected during childhood or as adults if they work around children. Pregnant women, who have not been infected with CMV in the past and become infected during pregnancy (i.e. a primary infection), may cause their babies to get infected with CMV. Babies that are infected may develop permanent disabilities including hearing loss and a small portion will die from the infection. Currently it is not routine practice to screen pregnant women for CMV infection. Additionally, there is no agreement about how to evaluate and manage pregnant women infected with CMV for the first time. There is also no evidence that treatment is beneficial for the baby. The purpose of this research study is to determine whether treating pregnant women who have a primary CMV infection with CMV antibodies will reduce the number of babies infected with CMV.
Primary Outcome
The primary outcome is a binary outcome defined by the occurrence or non-occurrence of any of the following vs. none of the following: fetal loss (spontaneous or termination), confirmed fetal CMV infection from amniocentesis, neonatal death before assessment of CMV infection can be made, or neonatal congenital CMV infection. Neonatal congenital CMV infection is diagnosed by urine or saliva collected by 3 weeks of age that is positive for CMV by culture (the intent will be to obtain in the first
Interventions
- OTHER Placebo
- DRUG CMV hyperimmune globulin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 399 participants |
| Start Date | 2012-04 |
| Est. Completion | 2021-06-30 |
| Phase | Phase 3 |
What the finished NCT01376778 record still lists
NCT01376778 is an interventional study that assigns participants to a tested intervention. The registered 399 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01376778 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01376778 about?
NCT01376778 is a clinical study titled "A Randomized Trial to Prevent Congenital Cytomegalovirus (CMV)". Cytomegalovirus (CMV) is a common virus that usually presents with few if any side effects. When first infected, some people may have symptoms similar to mononucleosis (i.e., fatigue, weakness, fever, swollen glands). Most people in the United States are infected during childhood or as adults if the...
What is the current status of trial NCT01376778?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 399 participants. The study started on 2012-04. Estimated completion is 2021-06-30.
What interventions are being tested in trial NCT01376778?
The interventions under investigation include: Placebo (OTHER), CMV hyperimmune globulin (DRUG).
Who is sponsoring clinical trial NCT01376778?
This trial is sponsored by The George Washington University Biostatistics Center, which has 24 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01376778's enrollment target sits among peer trials
399 962nd of 2000 higher than 1,038 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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