NCT00448227

Pharmacokinetics, Acceptability and Safety of Famciclovir in Infants (1 Month to Less Than 12 Months) With Herpes Simplex Infection

A Multicenter, Open-label, Single-arm Study to Evaluate the Single-dose Pharmacokinetics, Acceptability and Safety of Famciclovir Oral Pediatric Formulation in Infants 1 Month to Less Than 1 Year of Age With Herpes Simplex Virus Infections

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 1 Month – 1 Year
• Healthy volunteers: Not accepted

Summary

This study will evaluate the acceptability and safety of famciclovir in infants with herpes simplex infection

Conditions

• Herpes Simplex

Interventions

Type	Name	Description
DRUG	famciclovir	Administered orally as a single individualized dose between 25-200 mg based on body weight.

Timeline

• Start date: 2007-10-01
• Primary completion: 2008-11-01
• First posted: 2007-03-16
• Last updated: 2011-02-11
• Results posted: 2010-12-14

Locations

6 sites across 1 country: United States