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NCT00466817 · ClinicalTrials.gov registry record · Phase 3
Short-Term vs. Long-Term Valganciclovir Therapy for Symptomatic Congenital CMV Infections
A Phase 3 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 3
- Development phase
- 109
- Enrollment target
NCT00466817 is a Phase 3 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 109 participants.
The verdict
NCT00466817, a Phase 3 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 109 participants
- Enrollment target
Study Summary
Cytomegalovirus (CMV) infection is known to cause hearing loss and mental retardation. The purpose of this study is to compare a 6-week course to a 6-month course of the drug valganciclovir in babies born with CMV to assess the safety and efficacy of this treatment. Participants will include 104 infants (30 days old or younger) born with CMV disease. All infants will take valganciclovir by mouth for 6 weeks. At the end of the 6 week period, subjects will be assigned by chance to receive either valganciclovir or placebo (inactive substance) to complete the 6 months of antiviral treatment. Patients will be followed for the study related evaluations of safety, changes to hearing, and developmental milestones for up to 2 years. Patients will be followed by telephone contact for an additional 3 years. Thus, participants may be involved in study related procedures for approximately 5 years.
Interventions
- OTHER Placebo
- DRUG Valganciclovir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 109 participants |
| Start Date | 2008-06 |
| Est. Completion | 2013-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00466817
The ClinicalTrials.gov registry entry for NCT00466817 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 109 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00466817 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00466817 about?
NCT00466817 is a clinical study titled "Short-Term vs. Long-Term Valganciclovir Therapy for Symptomatic Congenital CMV Infections". Cytomegalovirus (CMV) infection is known to cause hearing loss and mental retardation. The purpose of this study is to compare a 6-week course to a 6-month course of the drug valganciclovir in babies born with CMV to assess the safety and efficacy of this treatment. Participants will include 104 inf...
What is the current status of trial NCT00466817?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 109 participants. The study started on 2008-06. Estimated completion is 2013-06.
What interventions are being tested in trial NCT00466817?
The interventions under investigation include: Placebo (OTHER), Valganciclovir (DRUG).
Who is sponsoring clinical trial NCT00466817?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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