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

Completed · Phase 3

Conditions studied: Chickenpox, Herpes Zoster

In brief

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.

Key facts

Study ID

NCT00098046

Run by

Novartis

People needed

76

Starts

2005-07-01

Expected to finish

2007-07-01

Last updated by the study team

2007-09-26

Who can join

Age: 1 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female children 1-12 years of age
• Clinical or laboratory evidence of varicella zoster infection
• Patients suspected of having varicella zoster infection

You may not qualify if…

• 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

Where it is running

• 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
• Novartis Investigational Site — Panama City, Panama

Full record on ClinicalTrials.gov

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