VALID2: Pharmacokinetics of Valacyclovir Oral Solution in Children

Sponsor

Radboud University Medical Center (Other)

Overall Status

Terminated

CT.gov ID

NCT04081480

Collaborator

(none)

Enrollment

Location

Arm

17.1

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Herpes Simplex Virus Infection Varicella Zoster Virus Infection	Drug: Valacyclovir	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

7 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Intervention is pharmacokinetic (PK) curve collection in children, two age groupsIntervention is pharmacokinetic (PK) curve collection in children, two age groups

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Pharmacokinetics of a New Paediatric Formulation of Valacyclovir Used for Prophylaxis and Treatment of Varicella Zoster Virus (VZV) and Herpes Simplex Virus (HSV) Infections in Children, Phase II (VALID II)

Actual Study Start Date :

Dec 10, 2019

Actual Primary Completion Date :

May 12, 2021

Actual Study Completion Date :

May 12, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: Valacyclovir oral solution 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

Arm

Intervention/Treatment

Other: Valacyclovir oral solution

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Number of adverse events [1 day]
Number of adverse events

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.