Pharmacokinetics of a new paediatric formulation of valacyclovir used for prophylaxis and treatment of VZV and HSV infections in children (VALID II).

Phase 4

Completed

• Conditions: chicken pox; herpes infection; 10047438

• Registration Number: NL-OMON50198
• Lead Sponsor: Afdeling Apotheek

Brief Summary

Trial ended prematurely

Detailed Description

Not available

Study Timeline

• Study Completion: 2021-05-12
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 7

Inclusion Criteria

1. Subject is in the age of 1-12 years.
2. Subject receives (val)acyclovir prophylaxis and is planned to receive
valacyclovir oral solution.
3. Subject is managed with a central venous catheter (CVC/Port-a-Cath).
4. Subject*s parents have signed the Informed Consent Form prior to screening
evaluations.

Exclusion Criteria

1. Severe anemia (Hb < 5.0 mmol/L).
2. Full dose has not been taken.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pharmacokinetic parameters of acyclovir: AUC0-12, Cmax and Cmin.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Amount and severity of adverse events</p><br>