Evaluation Of Valaciclovir In Patients With Chickenpox

GlaxoSmithKline43 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Varicella

Interventions

valaciclovir HCl granulesDRUG

Eligibility

Sex: ALLMin age: 1 YearMax age: 11 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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 Outcomes

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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.