Back to resultsPharmacokinetics of Valacyclovir Oral Solution in Children (VALID2)
Primary Purpose
Herpes Simplex Virus Infection, Varicella Zoster Virus Infection
Status
Terminated
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Valacyclovir
Sponsored by
About this trial
This is an interventional other trial for Herpes Simplex Virus Infection
Eligibility Criteria
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.
Sites / Locations
- Prinses Maxima Centrum voor kinderoncologie
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Valacyclovir oral solution
Arm Description
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.
Outcomes
Primary Outcome Measures
Area under the curve
Acyclovir area under the curve (12h)
Cmax
Maximum concentration of aciclovir
Tmax
Time to reach maximum concentration of aciclovir
Secondary Outcome Measures
Number of adverse events
Number of adverse events
Full Information
NCT ID
NCT04081480
First Posted
July 16, 2019
Last Updated
June 7, 2021
Sponsor
Radboud University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04081480
Brief Title
Pharmacokinetics of Valacyclovir Oral Solution in Children
Acronym
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)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Terminated
Why Stopped
Interim analysis showed positive results, it was difficult to include patients and also the fact that the grant for this project has ended, we have decided to complete the study before we had included the total number of 16 patients.
Study Start Date
December 10, 2019 (Actual)
Primary Completion Date
May 12, 2021 (Actual)
Study Completion Date
May 12, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Simplex Virus Infection, Varicella Zoster Virus Infection
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Intervention is pharmacokinetic (PK) curve collection in children, two age groups
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Valacyclovir oral solution
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Valacyclovir
Intervention Description
PK curve collection to determine acyclovir exposure after administration of valacyclovir oral solution
Primary Outcome Measure Information:
Title
Area under the curve
Description
Acyclovir area under the curve (12h)
Time Frame
12 hours
Title
Cmax
Description
Maximum concentration of aciclovir
Time Frame
12 hours
Title
Tmax
Description
Time to reach maximum concentration of aciclovir
Time Frame
12 hours
Secondary Outcome Measure Information:
Title
Number of adverse events
Description
Number of adverse events
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Prinses Maxima Centrum voor kinderoncologie
City
Utrecht
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pharmacokinetics of Valacyclovir Oral Solution in Children
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