Famciclovir Pediatric Formulation in Children 1 to 12 Years of Age With Herpes Simplex Infection

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the safety and blood levels of a new pediatric formulation of Famvir in children 1-12 years of age. In Part A, patients will receive a single dose of famciclovir (12.5 mg/kg) to assess pharmacokinetics (PK) and safety. In Part B, patients will receive multiple doses of famciclovir alone or with concomitant oral anti-herpes therapy to assess safety and tolerability. Part B will start only after PK data from Part A had been analyzed.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: 2-Aminopurine; Famciclovir

Criteria

Inclusion Criteria:

• History or laboratory evidence of herpes simplex infection

• Clinical evidence or suspicion of herpes simplex infection

Exclusion Criteria:

• Patients unable to swallow

• Concomitant use of probenecid

• Positive pregnancy test

Additional protocol-defined inclusion/exclusion criteria may apply. For detailed information on eligibility, please contact the study center nearest to you or call the following numbers: 1-862-778-3544 or 1-434-951-3228