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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04081480
Other study ID # VALID2
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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