Phase 2
N=18
Pharmacokinetics, Acceptability and Safety of Famciclovir in Infants (1 Month to Less Than 12 Months) With Herpes Simplex Infection
Herpes Simplex
Bottom Line
View on ClinicalTrials.gov: NCT00448227 ↗Enrolled (actual)
18
Serious AEs
5.6%
Results posted
Dec 2010
Primary outcome: Primary: Pharmacokinetics of Single Dose - Tmax — 1.00; 4; 1.02 hours
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- famciclovir (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Novartis
- Primary completion
- Nov 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics of Single Dose - Tmax |
1.00; 4; 1.02 | — |
| PRIMARY Pharmacokinetics of Single Dose - Cmax |
0.69; 0.74; 3.24 | — |
| PRIMARY Pharmacokinetics of Single Dose - AUC(0-tlast) |
2.09; 3.16; 8.68 | — |
| PRIMARY Pharmacokinetics of Single Dose - AUC(0-6h) |
2.22; 3.16; 8.77 | — |
| SECONDARY Safety Assessed by AEs, SAEs |
— | — |
| SECONDARY Safety Assessed by Labs |
— | — |
| SECONDARY Tolerability of of the Famciclovir Pediatric Formulation as Assessed by Study Personnel. |
1; 0; 0; 1; 0; 0 | — |
| SECONDARY Acceptability of the Famciclovir Pediatric Formulation as Assessed by the Patient's Caregiver |
1; 0; 0; 1; 0; 0 | — |
| SECONDARY Acceptability of the Famciclovir Pediatric Formulation as Assessed by Study Personnel |
1; 0; 0; 1; 0; 0 | — |
Summary
This study will evaluate the acceptability and safety of famciclovir in infants with herpes simplex infection
Eligibility Criteria
Inclusion Criteria
- Male and female patients from 1 month up to 1 year of age with herpes simplex infection
Exclusion Criteria
- Patients with gestational age less than 32 weeks. Patients unable to swallow. Patients with history of malabsorption or previous gastrointestinal surgery.
Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT00448227). 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.