At a glance
ClinicalIndex Comparison Record- ✓History or laboratory evidence of herpes simplex infection
- ✓Clinical evidence or suspicion of herpes simplex infection
- ✕Unable to swallow
- ✕Concomitant use of probenecid
- ✕Positive pregnancy test
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Open-label, Single-arm, Two-step Study to Evaluate the Safety and Single-dose Pharmacokinetics of Famciclovir and Multiple-dose Safety After Administration of Famciclovir Oral Pediatric Formulation to Children 1 to 12 Years of Age With Herpes Simplex Infection
In Brief
A Phase 3 clinical trial evaluating Famciclovir for Herpes Simplex. Completed, enrolled 74 participants across 13 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
Famciclovir sprinkle capsules, 25 mg and 100 mg, using OraSweet® syrup vehicle