Famciclovir Oral Pediatric Formulation in Children 1-12 Years of Age With Varicella Zoster Infection
- Conditions
- ChickenpoxHerpes Zoster
- Registration Number
- NCT00098046
- Lead Sponsor
- Novartis
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 76
- Male or female children 1-12 years of age
- Clinical or laboratory evidence of varicella zoster infection
- Patients suspected of having varicella zoster infection
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Step A: Single-dose safety and pharmacokinetics Step B: Safety and tolerability of pediatric formulation administered 3 times daily over 7 days
- Secondary Outcome Measures
Name Time Method Steps A & B: Acceptability of pediatric formulation by patients
Trial Locations
- Locations (2)
Novartis Investigational Site
π΅π¦David, Chiriqui, Panama
Columbia University Medical Center
πΊπΈNew York, New York, United States