Herpes simplex virus causes cold sores (fever blisters) and can lead to painful lesions in the mouth in healthy children. Children with impaired immune systems might develop severe complications. Famciclovir is a drug approved to treat herpes simplex and varicella zoster infection in adults. This study will evaluate the safety and blood levels of a new pediatric formulation of Famvir in children...
Date First Received: December 2, 2004
Last Updated: December 7, 2007
Verified by: Novartis, September 2007
Clinical Trial Phase: Phase 3 | Start Date: February 2005
Overall Status: Completed
Estimated Enrollment: 76
Brief Summary
Official Title: “A Multicenter, Open-Label, Single-Arm, Two-Step Study to Evaluate the Safety and Single-Dose Pharmacokinetics of Famciclovir and Multiple-Dose Safety After Administration of Famciclovir Oral Pediatric Formulation to Children 1 to 12 Years of Age With Herpes Simplex Infection”
Condition Keyword(s):
Intervention(s):
Herpes simplex virus causes cold sores (fever blisters) and can lead to painful lesions in the mouth in healthy children. Children with impaired immune systems might develop severe complications. Famciclovir is a drug approved to treat herpes simplex and varicella zoster infection in adults. This study will evaluate the safety and blood levels of a new pediatric formulation of Famvir in children 1-12 years of age.
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Intervention(s) in this Clinical Trial
- Drug: Famvir (famciclovir)
Outcome Measures for this Clinical Trial
Primary Measures
- Step A: single-dose safety and pharmacokinetics
- Step B: safety/tolerability of pediatric oral formulation administered 2 times daily over 7 days
Secondary Measures
- Step A & B: acceptability of pediatric oral formulation by patients
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- History or laboratory evidence of herpes simplex infection
- Clinical evidence or suspicion of herpes simplex infection
Exclusion Criteria:
- 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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 1 Year
Maximum Age for this Clinical Trial: 12 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Novartis
Additional Information
Information obtained from ClinicalTrials.gov on September 05, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00098059
Study ID Number: CFAM810B2303
ClinicalTrials.gov Identifier: NCT00098059
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
