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

Pharmacokinetics of a new paediatric formulation of valacyclovir used for prophylaxis and treatment of VZV and HSV infections in children (VALID II). - VALID-2

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50198

Enrollment

Registered

2019-04-16

Start date

2020-01-20

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chicken pox herpes infection

Interventions

Intake of valacyclovir oral solution (as standard of care) and collection of bloodsamples for determination of the pharmacokinetics.

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

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

Exclusion criteria: 1. Severe anemia (Hb

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic parameters of acyclovir: AUC0-12, Cmax and Cmin.	—

Secondary

Measure	Time frame
Amount and severity of adverse events	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)