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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00297206 | A Safety And Tolerability Study Of Valaciclovir Oral Suspension In Infants And Children | PHASE1 | COMPLETED | 36 | — | — | Jan 25, 2003 | Feb 28, 2007 | Sep 11, 2017 | 13 | United States, Chile +1 |
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Subjects in the age group of 2 to less than 6 years will be included |
| Cohort 2 | EXPERIMENTAL | Subjects in the age group of 1 to less than 2 years will be included |
| Cohort 3 | EXPERIMENTAL | Subjects in the age group of 6 months to less than 1 year will be included |
| Cohort 4 | EXPERIMENTAL | Subjects in the age group of 3 months to less than 6 months will be included |
| Cohort 5 | EXPERIMENTAL | Subjects in the age group of 1 month to less than 3 months will be included |
| Name | Type | Description |
|---|---|---|
| Valaciclovir | DRUG | Valaciclovir will be administered as an extemporaneously prepared suspension formulation. Valaciclovir oral suspension will be prepared by crushing marketed Valtrex Caplets 500 milligram (mg) and suspending the resultant powder in Suspension Structured Vehicle USNF with dose strength of 25 milligram per milliliter (mg/mL) or 50 mg/mL. |
Inclusion criteria: * Subjects who have a current herpes virus infection. * Have neonatally acquired herpes at risk of potential recurrence. * Immunocompromised or cancer patients at risk for development of a herpes virus infection. Exclusion criteria: * Hypersensitivity to antiherpetic medicatio...