Evaluation Of Valaciclovir In Patients With Chickenpox

Clinical Evaluation of Valaciclovir Hydrochloride: 256U87 in Patients With Chickenpox - Open Uncontrolled Study.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00169416

Enrollment

Registered

2005-09-15

Start date

2005-03-31

Completion date

2005-08-31

Last updated

2015-04-15

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

Conditions

Varicella

Keywords

chicken pox, varicella, VZV, pharmacokinetics

Brief summary

This study will assess the safety and efficacy, and the pharmacokinetics of aciclovir and valaciclovir in children with chickenpox following oral administration of valaciclovir, for the purpose of seeking approval of valaciclovir HCl for the treatment of chickenpox.

Interventions

DRUGvalaciclovir HCl granules

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to 11 Years

Healthy volunteers

Inclusion criteria

* Subjects aged 1 year to less than 12 years with a clinical diagnosis of chickenpox within 48 hours of the onset of the rash.

Exclusion criteria

* History of hypersensitivity reactions. * Impaired hepatic or renal function. * Gastrointestinal dysfunction. * Serious underlying disease. * Weigh over 40kg. * Vaccinated for chickenpox.

Design outcomes

Primary

Measure	Time frame
Plasma aciclovir concentrations approximately 1 - 2 hours post-dose, and/or 1, 2, 4 and 6 hours following administration of the valaciclovir HCl granules 25mg/kg -dose.	—

Secondary

Measure	Time frame
Plasma valaciclovir concentrations approximately 1 - 2 hours post-dose, and/or 1, 2, 4 and 6 hours following administration of the valaciclovir HCl granules 25mg/kg -dose.	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026