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

Novartis

Status and phase: Completed; Phase 3

Conditions: Herpes Simplex

Treatments: Drug: Famciclovir

Study type: Interventional

Funder types: Industry

Identifiers

NCT00098059

CFAM810B2303

Details and patient eligibility

About

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.

Enrollment: 74 patients

Sex: All

Ages: 1 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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74 participants in 1 patient group

Famciclovir, pediatric oral formulation

Experimental group

Description:

single-arm

Treatment:

Drug: Famciclovir