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

Novartis

Status and phase: Completed; Phase 3

Conditions: Herpes Zoster; Chickenpox

Treatments: Drug: famciclovir

Study type: Interventional

Funder types: Industry

Identifiers

NCT00098046

CFAM810B2304

Details and patient eligibility

About

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.

Enrollment: 76 estimated patients

Sex: All

Ages: 1 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)