Famciclovir Oral Pediatric Formulation in Children 1-12 Years of Age With Varicella Zoster Infection

Novartis76 enrolled

Overview

Varicella zoster virus causes chickenpox in children and shingles in adults. Chickenpox is usually a self-limiting illness characterized by fever and a rash. Serious complications can include secondary bacterial infections, pneumonia, and encephalitis. Anti-viral treatment is not a standard of care in immunocompetent children, but is recommended whenever a risk of complication exists. This study will evaluate the safety and blood levels of a new formulation of famciclovir in children 1-12 years of age.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chickenpox Herpes Zoster

Interventions

famciclovirDRUG

Eligibility

Sex: ALLMin age: 1 YearMax age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female children 1-12 years of age * Clinical or laboratory evidence of varicella zoster infection * Patients suspected of having varicella zoster infection Exclusion Criteria: * Patients unable to swallow * Concomitant use of probenecid * Positive pregnancy Additional protocol-defined inclusion/exclusion criterial may apply. For detailed information on eligibility, please contact the study center nearest to you (see below), or call the following number 1-862-778-3544 or 1-434-951-3228

Locations (5)

Columbia University Medical Center

New York, New York, United States

Novartis Investigational Site

San José, Costa Rica

Novartis Investigational Site

Cuidad de Guatemala, Guatemala

Novartis Investigational Site

David, Chiriqui, Panama

Outcomes

Primary Outcomes

Step A: Single-dose safety and pharmacokinetics

Step B: Safety and tolerability of pediatric formulation administered 3 times daily over 7 days

Secondary Outcomes

Steps A & B: Acceptability of pediatric formulation by patients

Data from ClinicalTrials.gov

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