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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00098046

Enrollment

Registered

2004-12-03

Start date

2005-07-31

Completion date

2007-07-31

Last updated

2007-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chickenpox, Herpes Zoster

Keywords

chickenpox, herpes zoster, children, Famvir, varicella zoster virus

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.

Interventions

DRUGfamciclovir

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to 12 Years

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/

Design outcomes

Primary

Measure	Time frame
Step A: Single-dose safety and pharmacokinetics	—
Step B: Safety and tolerability of pediatric formulation administered 3 times daily over 7 days	—

Secondary

Measure	Time frame
Steps A & B: Acceptability of pediatric formulation by patients	—

Countries

Costa Rica, Guatemala, Panama, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026