Famciclovir Oral Pediatric Formulation in Children 1-12 Years of Age With Varicella Zoster Infection
Pharmacokinetics and Safety of Famciclovir Oral Pediatric Formulation in Children 1-12 Years of Age With Varicella Zoster Infection
1 other identifier
interventional
76
4 countries
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jul 2005
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 2, 2004
CompletedFirst Posted
Study publicly available on registry
December 3, 2004
CompletedStudy Start
First participant enrolled
July 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedSeptember 26, 2007
September 1, 2007
December 2, 2004
September 25, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Step A: Single-dose safety and pharmacokinetics
Step B: Safety and tolerability of pediatric formulation administered 3 times daily over 7 days
Secondary Outcomes (1)
Steps A & B: Acceptability of pediatric formulation by patients
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (5)
Columbia University Medical Center
New York, New York, 10032, 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
Related Publications (1)
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: 19273678DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 2, 2004
First Posted
December 3, 2004
Study Start
July 1, 2005
Study Completion
July 1, 2007
Last Updated
September 26, 2007
Record last verified: 2007-09