Pharmacokinetics of Valacyclovir Oral Solution in Children

Not Applicable

Terminated

• Conditions: Varicella Zoster Virus Infection; Herpes Simplex Virus Infection
• Interventions: Drug: Valacyclovir

• Registration Number: NCT04081480
• Lead Sponsor: Radboud University Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-16
• Study First Submitted QC: 2019-09-04
• Study First Posted: 2019-09-09
• Study Start: 2019-12-10
• Primary Completion: 2021-05-12
• Study Completion: 2021-05-12
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-07
• Last Update Posted: 2021-06-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

• Subject is in the age of 2-12 years.
• Subject has an indication for (val)acyclovir prophylaxis and are planned to receive valacyclovir oral solution.
• Subject is managed with a central venous catheter (CVC/Port-a-Cath).
• Subject's parents have signed the Informed Consent Form prior to screening evaluations.
• Subject is willing to participate after study procedures are explained in comprehensible language for the child.

Exclusion Criteria

• Severe anemia (<6.0 mmol/L).
• Full dose has not been taken.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Valacyclovir oral solution	Valacyclovir	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.

Primary Outcome Measures

Name	Time	Method
Tmax	12 hours	Time to reach maximum concentration of aciclovir
Area under the curve	12 hours	Acyclovir area under the curve (12h)
Cmax	12 hours	Maximum concentration of aciclovir

Secondary Outcome Measures

Name	Time	Method
Number of adverse events	1 day	Number of adverse events

Trial Locations

Locations (1)

Prinses Maxima Centrum voor kinderoncologie; 🇳🇱 Utrecht, Netherlands