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

Completed · Phase 3

Conditions studied: Herpes Simplex

In brief

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) to assess pharmacokinetics (PK) and safety. In Part B, patients will receive multiple doses of famciclovir alone or with concomitant oral anti-herpes therapy to assess safety and tolerability. Part B will start only after PK data from Part A had been analyzed.

Key facts

Study ID

NCT00098059

Run by

Novartis Pharmaceuticals

People needed

74

Starts

2005-02-01

Expected to finish

2007-12-01

Last updated by the study team

2013-04-25

Who can join

Age: 1 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• The Children's Hospital — Denver, Colorado, United States
• Children's Memorial Hospital — Chicago, Illinois, United States
• Kosair Charities Pediatric Clinical Research Unit — Louisville, Kentucky, United States
• Columbia University Medical Center — New York, New York, United States
• State University of New York at — Stony Brook, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• University Hospitals of Cleveland — Cleveland, Ohio, United States
• Children's Medical Center of Dallas — Dallas, Texas, United States
• Baylor College of Medicine/Texas Children's Hospital — Houston, Texas, United States
• Panama Minister of Health — David, Chiriquí Province, Panama
• Panama Minister of Health — Panama City, Panama

Full record on ClinicalTrials.gov

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