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

NCT00098046 — Phase 3, Completed, 76 participants, Novartis

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

Registry	NCT00098046
Status	Completed
Phase	Phase 3
Study type	Interventional; non randomized, single group, masking: none, treatment
Enrollment	76 (Estimated)
Sponsor	Novartis (Industry)
Conditions	Chickenpox, Herpes Zoster
Interventions	famciclovir (Drug)
Dates	start 2005-07-01, completion 2007-07-01, first posted 2004-12-03, last updated 2007-09-26
Locations	5 sites in United States, Costa Rica, Guatemala, Panama

-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.

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+Arms and interventions

famciclovir (Drug)

+Outcome measures

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

+Eligibility

Sex: All, ages: 1 Year to 12 Years

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)

Facility	City	Country
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

+Publications

Results publication: Saez-Llorens X, Yogev R, Arguedas A, Rodriguez A, Spigarelli MG, De Leon Castrejon T, Bomgaars L, Roberts M, Abrams B, Zhou W, Looby M, Kaiser G, Hamed K. Pharmacokinetics and safety of famciclovir in children with herpes simplex or varicella-zoster virus infection. Antimicrob Agents Chemother. 2009 May;53(5):1912-20. doi: 10.1128/AAC.01054-08. Epub 2009 Mar 9. PMID 19273678

+Investigators

Novartis Pharmaceuticals, Study chair, Novartis Pharmaceuticals