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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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