Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00031434 · ClinicalTrials.gov registry record · Phase 1
Valganciclovir in Congenital CMV Infants
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT00031434: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00031434 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00031434, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate how ganciclovir is metabolized when administered intravenously (by a needle inserted into a vein) following valganciclovir syrup, given by mouth to newborns and young infants with symptoms of congenital (present at birth) cytomegalovirus (CMV) disease. The study also seeks to identify a dose of valganciclovir that provides a comparable blood concentration to ganciclovir present in the blood of newborns with symptomatic congenital CMV disease. All study participants will receive 6 weeks of antiviral therapy (defined as ganciclovir and/or valganciclovir). Infants from 0 to 30 days old will participate in the study for 2 years.
Interventions
- DRUG Valganciclovir
- DRUG Ganciclovir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2002-07 |
| Est. Completion | 2007-07 |
| Phase | Phase 1 |
What the finished NCT00031434 record still lists
NCT00031434 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Valganciclovir is the first listed.
NCT00031434 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00031434 about?
NCT00031434 is a clinical study titled "Valganciclovir in Congenital CMV Infants". The purpose of this study is to evaluate how ganciclovir is metabolized when administered intravenously (by a needle inserted into a vein) following valganciclovir syrup, given by mouth to newborns and young infants with symptoms of congenital (present at birth) cytomegalovirus (CMV) disease. The st...
What is the current status of trial NCT00031434?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2002-07. Estimated completion is 2007-07.
What interventions are being tested in trial NCT00031434?
The interventions under investigation include: Valganciclovir (DRUG), Ganciclovir (DRUG).
Who is sponsoring clinical trial NCT00031434?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00031434's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02331979 · 24 participants · NA
Improving Bladder Function in SCI by Neuromodulation
- NCT03096197 · 24 participants · NA
Exoskeleton and Spinal Cord Stimulation for SCI
- NCT03223922 · 24 participants · NA
Neurocognitive Functioning With Genu-Sparing Whole Brain Radiation Therapy for Brain Metastases
- NCT03326921 · 24 participants · Phase 1
HA-1 T TCR T Cell Immunotherapy for the Treatment of Patients With Relapsed or Refractory Acute Leukemia After Donor Stem Cell Transplant
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia