Pharmacokinetics of Valacyclovir Oral Solution in Children

NCT04081480 | Terminated

• 1 other identifier: VALID2
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Herpes Simplex Virus Infection; Varicella Zoster Virus Infection

Outcome Measures

Primary Outcomes (3)

• Area under the curve

  Acyclovir area under the curve (12h)

  12 hours

• Cmax

  Maximum concentration of aciclovir

  12 hours

• Tmax

  Time to reach maximum concentration of aciclovir

  12 hours

Secondary Outcomes (1)

• Number of adverse events

  1 day

Study Arms (1)

Valacyclovir oral solution

OTHER

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

Interventions

Valacyclovir DRUG

PK curve collection to determine acyclovir exposure after administration of valacyclovir oral solution

Valacyclovir oral solution

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Prinses Maxima Centrum voor kinderoncologie

Utrecht, Netherlands

Location

MeSH Terms

Conditions

Herpes Simplex; Varicella Zoster Virus Infection

Interventions

Valacyclovir

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intervention is pharmacokinetic (PK) curve collection in children, two age groups

Study Record Dates

• First Submitted: July 16, 2019
• First Posted: September 9, 2019
• Study Start: December 10, 2019
• Primary Completion: May 12, 2021
• Study Completion: May 12, 2021
• Last Updated: June 10, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)