Pharmacokinetics, Acceptability and Safety of Famciclovir in Infants (1 Month to Less Than 12 Months) With Herpes Simplex Infection
Information source: Novartis
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Herpes Simplex
Intervention: famciclovir (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Novartis Official(s) and/or principal investigator(s): Novartis, Principal Investigator, Affiliation: Novartis Dr. Jeffery L. Blumer, Principal Investigator, Affiliation: University Hospital Cased Medical Center Rainbow Babies and Children's Hospital, Cleveland, OH
Summary
This study will evaluate the acceptability and safety of famciclovir in infants with herpes
simplex infection
Clinical Details
Official title: A Multicenter, Open-label, Single-arm Study to Evaluate the Single-dose Pharmacokinetics, Acceptability and Safety of Famciclovir Oral Pediatric Formulation in Infants 1 Month to Less Than 1 Year of Age With Herpes Simplex Virus Infections
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Pharmacokinetics of Single Dose - TmaxPharmacokinetics of Single Dose - Cmax Pharmacokinetics of Single Dose - AUC(0-tlast) Pharmacokinetics of Single Dose - AUC(0-6h)
Secondary outcome: Safety Assessed by AEs, SAEsSafety Assessed by Labs Tolerability of of the Famciclovir Pediatric Formulation as Assessed by Study Personnel. Acceptability of the Famciclovir Pediatric Formulation as Assessed by the Patient's Caregiver Acceptability of the Famciclovir Pediatric Formulation as Assessed by Study Personnel
Eligibility
Minimum age: 1 Month.
Maximum age: 1 Year.
Gender(s): Both.
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.
Locations and Contacts
Pediatric Infectious Disease Of University of Alabama, Birmingham, Alabama, United States
Children's Memorial Hospital Chicago, Chicago, Illinois, United States
Children's Hospital of Michigan, Detroit, Michigan, United States
Archana Chatterjee, Omaha, Nebraska 68131, United States
University Hospital Cased Medical Center Rainbow Babies and Children's Hospital, Cleveland, Ohio, United States
UT Southwestern Medical Center, Dallas, Texas, United States
Additional Information
Starting date: October 2007
Last updated: February 9, 2011
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