Status:

COMPLETED

Famciclovir Pediatric Formulation in Children 1 to 12 Years of Age With Herpes Simplex Infection

Lead Sponsor:

Novartis Pharmaceuticals

Conditions:

Herpes Simplex

Eligibility:

All Genders

1-12 years

Phase:

PHASE3

Brief Summary

This study will evaluate the safety and blood levels of a new pediatric formulation of Famvir in children 1-12 years of age. In Part A, patients will receive a single dose of famciclovir (12.5 mg/kg) ...

Eligibility Criteria

Inclusion

  • History or laboratory evidence of herpes simplex infection
  • Clinical evidence or suspicion of herpes simplex infection

Exclusion

  • Patients unable to swallow
  • Concomitant use of probenecid
  • Positive pregnancy test
  • Additional protocol-defined inclusion/exclusion criteria may apply. For detailed information on eligibility, please contact the study center nearest to you or call the following numbers: 1-862-778-3544 or 1-434-951-3228

Key Trial Info

Start Date :

February 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2007

Estimated Enrollment :

74 Patients enrolled

Trial Details

Trial ID

NCT00098059

Start Date

February 1 2005

End Date

December 1 2007

Last Update

April 25 2013

Active Locations (13)

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Page 1 of 4 (13 locations)

1

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35233-1711

2

The Children's Hospital

Denver, Colorado, United States, 80218

3

Children's Memorial Hospital

Chicago, Illinois, United States, 60614

4

Kosair Charities Pediatric Clinical Research Unit

Louisville, Kentucky, United States, 40202-3830