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NCT04448392 · ClinicalTrials.gov registry record · Phase 1
Valacyclovir in Neonatal Herpes Simplex Virus Disease
A Phase 1 study, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
NCT04448392: Completed Phase 1 study, sponsored by University of Alabama at Birmingham.
NCT04448392 is a Phase 1 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 7 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04448392, a Phase 1 study, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
Study Summary
This is an open-label, single center, pharmacokinetic (PK) study to assess valacyclovir pharmacokinetics and pharmacodynamics in neonates and compare to the pharmacokinetics and pharmacodynamics of the standard of care treatment dose of intravenous acyclovir. 6 (up to 10 infants) with virologically confirmed neonatal herpes simplex virus (HSV) disease who meet all inclusion/exclusion criteria will be enrolled in the study. Study duration is 5 years. Primary objective is to define the pharmacokinetics of valacyclovir and assess its safety in neonates 2-12 weeks of age who are ≥ 34 weeks gestation.
Primary Outcome
Blood will be collected to determine the drug concentration of acyclovir, the metabolite of valacyclovir and will include AUC.
Interventions
- DRUG Valacyclovir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2021-07-01 |
| Est. Completion | 2024-07-24 |
| Phase | Phase 1 |
What the finished NCT04448392 record still lists
NCT04448392 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 1 intervention - of which Valacyclovir is the first listed.
NCT04448392 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04448392 about?
NCT04448392 is a clinical study titled "Valacyclovir in Neonatal Herpes Simplex Virus Disease". This is an open-label, single center, pharmacokinetic (PK) study to assess valacyclovir pharmacokinetics and pharmacodynamics in neonates and compare to the pharmacokinetics and pharmacodynamics of the standard of care treatment dose of intravenous acyclovir. 6 (up to 10 infants) with virologically ...
What is the current status of trial NCT04448392?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2021-07-01. Estimated completion is 2024-07-24.
What interventions are being tested in trial NCT04448392?
The interventions under investigation include: Valacyclovir (DRUG).
Who is sponsoring clinical trial NCT04448392?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04448392's enrollment target sits among peer trials
7 1972nd of 2000 higher than 27 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
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