This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.ABSTRACT HYPOTHESIS Famciclovir will be safe and well tolerated in pediatric patients with HSV infections.
SPECIFIC AIMS Study purpose: To obtain safety and pharmacokinetic data in single dose and multiple dose evaluations in children ages 1 to 12 who are infected with HSV. The results of this study will support the optimal use of famciclovir by providing data to give dosing recommendations and a better understanding of the safety and tolerability profile in pediatric patients with herpes simplex infections.This study is an open-label, multiple-dose, single-arm study with a two-step design: + Part A: consists of a single dose safety and pharmacokinetic assessment, after exposure to 12.5 mg /kg regardless of the patient's immune status. The purpose of Part A is to document safety and tolerability of famciclovir and to confirm the PK model, predicting that in children the dose of 12.5 mg/kg (for less than 40kg, or 500 mg for more than 40kg body weight) provides a similar exposure as the dose of 500 mg in adults. Based upon the results from the pharmacokinetic dosing from Part A, dose will be re-adjusted if necessary and study will continue with Part B of the trial (see Section 10.4.4 Supportive analysis in Full Protocol). Part B will start only after the PK data from Part A have been analyzed.+ Part B: consists of a multiple dose safety and tolerability assessment. Finally, pharmacokinetic and multiple dose safety data will be submitted to the FDA, together with two other trials, that are part of the pediatric program for famciclovir. ObjectivesThe primary objectives of study Part A are:+ to evaluate the safety and tolerability of a single dose of famciclovir in children from 1 to 12 years of age with herpes simplex virus infection. + to evaluate the pharmacokinetics of a single dose of famciclovir and its relationship to age and body weight after administration of a single dose oral formulation of famciclovir to pediatric patients from 1 to 12 years of age with herpes simplex virus infection, in order to define the dose in children which gives a similar exposure than a 500mg dose gives in adults. If a single weight adjusted dose (in mg /kg) for all children in the age range 1-12 years is not possible, dosing recommendation based on age subgroups will be developed. The secondary objective of Part A is to assess acceptability of the pediatric formulation by the patients.The primary objective of Part B of the study is:+ to explore the safety and tolerability of multiple dosing of famciclovir administered twice daily over 7 days in pediatric patients from 1 to 12 years of age who have infection with herpes simplex virus. The secondary objective of Part B is:+ to assess acceptability of the pediatric formulation by the patients.An exploratory analysis will be performed to assess overall response to treatment in each individual patient.
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