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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 - Tmax

Pharmacokinetics of Single Dose - Cmax

Pharmacokinetics of Single Dose - AUC(0-tlast)

Pharmacokinetics of Single Dose - AUC(0-6h)

Secondary outcome:

Safety Assessed by AEs, SAEs

Safety 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

Page last updated: August 20, 2015

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