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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 is a Phase 1 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 7 participants.
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.
Interventions
- DRUG Valacyclovir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2021-07-01 |
| Est. Completion | 2024-07-24 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04448392
The ClinicalTrials.gov registry entry for NCT04448392 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Valacyclovir is the first listed.
NCT04448392 reports 0 study locations.
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.
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