Pharmacokinetics of Valacyclovir Oral Solution in Children

Varicella Zoster Virus Infection Clinical Trial

— VALID2  

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04081480
• Other study ID #: VALID2
• Status: Terminated
• Phase: N/A
• Start date: December 10, 2019
• Est. completion date: May 12, 2021

Study information

• Verified date: June 2021
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: May 12, 2021
• Est. primary completion date: May 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chickenpox
• Communicable Diseases
• Herpes Simplex
• Herpes Simplex Virus Infection
• Herpes Zoster
• Infection
• Varicella Zoster Virus Infection
• Virus Diseases

Intervention

Drug:
• Valacyclovir
PK curve collection to determine acyclovir exposure after administration of valacyclovir oral solution

Locations

Country	Name	City	State
Netherlands	Prinses Maxima Centrum voor kinderoncologie	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve	Acyclovir area under the curve (12h)	12 hours
Primary	Cmax	Maximum concentration of aciclovir	12 hours
Primary	Tmax	Time to reach maximum concentration of aciclovir	12 hours
Secondary	Number of adverse events	Number of adverse events	1 day