Pharmacokinetics of Valacyclovir Oral Solution in Children
NCT ID: NCT04081480
Last Updated: 2021-06-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
7 participants
INTERVENTIONAL
2019-12-10
2021-05-12
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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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.
Valacyclovir
PK curve collection to determine acyclovir exposure after administration of valacyclovir oral solution
Interventions
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Valacyclovir
PK curve collection to determine acyclovir exposure after administration of valacyclovir oral solution
Eligibility Criteria
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Inclusion Criteria
* 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
* Full dose has not been taken.
2 Years
12 Years
ALL
No
Sponsors
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Radboud University Medical Center
OTHER
Responsible Party
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Locations
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Prinses Maxima Centrum voor kinderoncologie
Utrecht, , Netherlands
Countries
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Other Identifiers
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VALID2
Identifier Type: -
Identifier Source: org_study_id
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