Evaluation Of Valaciclovir In Patients With Chickenpox

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Varicella

Treatments: Drug: valaciclovir HCl granules

Study type: Interventional

Funder types: Industry

Identifiers

NCT00169416

HS2101951

Details and patient eligibility

About

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.

Enrollment: 43 patients

Sex: All

Ages: 1 to 11 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)