An interventional study of Valacyclovir in Herpes Simplex Virus Infection and Varicella Zoster Virus Infection, sponsored by Radboud University Medical Center. Terminated at 1 site in Netherlands. Open to participants aged 2 Years to 12 Years. Per ClinicalTrials.gov, last updated 2021-06-10.
Sponsored by Radboud University Medical Center · Not applicable, Interventional, and Other
Valacyclovir has replaced acyclovir in many clinical scenarios. Pharmacokinetic data support the use of oral valacyclovir in children, but practical problems exist in children having to take adult-dose tablets. A formulation with acceptable palatability, good pharmaceutical quality and possibility of flexible dosing is developed. Pharmacokinetic data of this formulation is missing.
The present study investigates the pharmacokinetics of valacyclovir oral solution in children by determine the area under the curve (AUC0-12), time above critical concentration (Ccrit), Cmax and Tmax of acyclovir.
Secondary, the safety profile of a single dose of valacyclovir oral solution will be determined.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 7 is below the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Valacyclovir oral solution as administered in standard of care. Dosage: 10 mg/kg BID for children weighing less than 40 kg and 500 mg BID for children weighing 40 kg or more.
Drug: Valacyclovir
PK curve collection to determine acyclovir exposure after administration of valacyclovir oral solution
Area under the curve
Acyclovir area under the curve (12h)
Time frame: 12 hours
Cmax
Maximum concentration of aciclovir
Time frame: 12 hours
Tmax
Time to reach maximum concentration of aciclovir
Time frame: 12 hours
Number of adverse events
Number of adverse events
Time frame: 1 day
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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Radboud University Medical Center