Pharmacokinetics, Acceptability and Safety of Famciclovir in Infants (1 Month to Less Than 12 Months) With Herpes Simplex Infection

Completed · Phase 2

Conditions studied: Herpes Simplex

In brief

This study will evaluate the acceptability and safety of famciclovir in infants with herpes simplex infection

Key facts

Study ID

NCT00448227

Run by

Novartis

People needed

18

Starts

2007-10-01

Last updated by the study team

2011-02-11

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female patients from 1 month up to 1 year of age with herpes simplex infection

You may not qualify if…

• 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.

Where it is running

• 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, 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

Full record on ClinicalTrials.gov

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