Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00098059 | Famciclovir Pediatric Formulation in Children 1 to 12 Years of Age With Herpes Simplex Infection | PHASE3 | COMPLETED | 74 | — | — | Feb 1, 2005 | Dec 1, 2007 | Apr 25, 2013 | 13 | United States, Panama |
| NCT00448227 | Pharmacokinetics, Acceptability and Safety of Famciclovir in Infants (1 Month to Less Than 12 Months) With Herpes Simplex Infection | PHASE2 | COMPLETED | 18 | — | — | Oct 1, 2007 | - | Feb 11, 2011 | 6 | United States |
A patient with multiple adverse events (AEs) within the primary system organ class is counted only once in total row.
PK parameter; penciclovir is the active metabolite of famciclovir.
PK parameter; penciclovir is the active metabolite of famciclovir.
PK parameter; penciclovir is the active metabolite of famciclovir.
PK parameter; penciclovir is the active metabolite of famciclovir.
PK parameter; penciclovir is the active metabolite of famciclovir
A patient with multiple AEs within the primary system organ class is counted only once in total row.
Measured by Tmax - The time after administration of a drug when the maximum plasma concentration is reached.
Measured by Cmax - The maximum plasma concentration of study medication
Measured by AUC(0-tlast) - Area under the plasma concentration time curve from time zero to the last quantifiable concentration-timepoint.
Measured by AUC(0-6h) - Area under the plasma concentration time curve from time zero up to 6 hours post dose (i.e. the time of the last sample).
| Arm | Type | Description |
|---|---|---|
| Famciclovir, pediatric oral formulation | EXPERIMENTAL | single-arm |
| Famciclovir | EXPERIMENTAL | Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight. |
| Name | Type | Description |
|---|---|---|
| Famciclovir | DRUG | Famciclovir sprinkle capsules, 25 mg and 100 mg, using OraSweet® syrup vehicle |
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...