Phase 3
Completed N=74
Famciclovir Pediatric Formulation in Children 1 to 12 Years of Age With Herpes Simplex Infection
Source: ClinicalTrials.gov NCT00098059 ↗Enrolled (actual)
74
Serious AEs
0.0%
Results posted
May 2009
Primary outcomePrimary: Safety and Tolerability of a Single-dose of Famciclovir in Part A of the Study. — 0; 2; 1; 2 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Tolerability of a Single-dose of Famciclovir in Part A of the Study. |
0; 2; 1; 2; 0; 1 | — |
| PRIMARY Maximum Observed Plasma Concentration of Penciclovir (Cmax) |
2.84; 2.44; 2.82; 1.89 | — |
| PRIMARY Time of Maximum Observed Plasma Concentration of Penciclovir (Tmax) |
1.21; 1.07; 1.00; 1.47 | — |
| PRIMARY Area Under the Penciclovir Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-∞) |
6.17; 6.85; 8.15; 5.93 | — |
| PRIMARY Apparent Oral Clearance of Penciclovir (CL/F) |
20.8; 25.1; 43.7; 68.8 | — |
| PRIMARY Apparent Terminal Elimination Half-life of Penciclovir (T1/2) |
1.09; 1.36; 1.60; 1.86 | — |
| PRIMARY Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study. |
6; 8; 12; 4; 3; 6 | — |
| SECONDARY Overall Acceptability of Pediatric Oral Formulation by Patients in Part A of the Study. |
1; 4; 0; 2; 1; 1 | — |
| SECONDARY Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study. |
9; 6; 7; 2; 1; 2 | — |
| SECONDARY Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study |
7; 5; 3; 3; 3; 3 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00098059). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.