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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 is a Phase 3 study that has completed, run by The George Washington University Biostatistics Center. The registered enrollment target is 399 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01376778
The ClinicalTrials.gov registry entry for NCT01376778 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 399 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The George Washington University Biostatistics Center, which has 24 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01376778 reports 0 study locations.
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.
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