Back to resultsFamciclovir Oral Pediatric Formulation in Children 1-12 Years of Age With Varicella Zoster Infection
Primary Purpose
Chickenpox, Herpes Zoster
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
famciclovir
Sponsored by
About this trial
This is an interventional treatment trial for Chickenpox focused on measuring chickenpox, herpes zoster, children, Famvir, varicella zoster virus
Eligibility Criteria
Inclusion Criteria: Male or female children 1-12 years of age Clinical or laboratory evidence of varicella zoster infection Patients suspected of having varicella zoster infection Exclusion Criteria: Patients unable to swallow Concomitant use of probenecid Positive pregnancy Additional protocol-defined inclusion/exclusion criterial may apply. For detailed information on eligibility, please contact the study center nearest to you (see below), or call the following number 1-862-778-3544 or 1-434-951-3228
Sites / Locations
- Columbia University Medical Center
- Novartis Investigational Site
- Novartis Investigational Site
- Novartis Investigational Site
- Novartis Investigational Site
Outcomes
Primary Outcome Measures
Step A: Single-dose safety and pharmacokinetics
Step B: Safety and tolerability of pediatric formulation administered 3 times daily over 7 days
Secondary Outcome Measures
Steps A & B: Acceptability of pediatric formulation by patients
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00098046
Brief Title
Famciclovir Oral Pediatric Formulation in Children 1-12 Years of Age With Varicella Zoster Infection
Official Title
Pharmacokinetics and Safety of Famciclovir Oral Pediatric Formulation in Children 1-12 Years of Age With Varicella Zoster Infection
Study Type
Interventional
2. Study Status
Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief Summary
Varicella zoster virus causes chickenpox in children and shingles in adults. Chickenpox is usually a self-limiting illness characterized by fever and a rash. Serious complications can include secondary bacterial infections, pneumonia, and encephalitis. Anti-viral treatment is not a standard of care in immunocompetent children, but is recommended whenever a risk of complication exists. This study will evaluate the safety and blood levels of a new formulation of famciclovir in children 1-12 years of age.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chickenpox, Herpes Zoster
Keywords
chickenpox, herpes zoster, children, Famvir, varicella zoster virus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
76 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
famciclovir
Primary Outcome Measure Information:
Title
Step A: Single-dose safety and pharmacokinetics
Title
Step B: Safety and tolerability of pediatric formulation administered 3 times daily over 7 days
Secondary Outcome Measure Information:
Title
Steps A & B: Acceptability of pediatric formulation by patients
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female children 1-12 years of age
Clinical or laboratory evidence of varicella zoster infection
Patients suspected of having varicella zoster infection
Exclusion Criteria:
Patients unable to swallow
Concomitant use of probenecid
Positive pregnancy
Additional protocol-defined inclusion/exclusion criterial may apply. For detailed information on eligibility, please contact the study center nearest to you (see below), or call the following number 1-862-778-3544 or 1-434-951-3228
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Chair
Facility Information:
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Novartis Investigational Site
City
San Jose
Country
Costa Rica
Facility Name
Novartis Investigational Site
City
Cuidad de Guatemala
Country
Guatemala
Facility Name
Novartis Investigational Site
City
Ciudad de Panama
Country
Panama
Facility Name
Novartis Investigational Site
City
David, Chiriqui
Country
Panama
12. IPD Sharing Statement
Citations:
PubMed Identifier
19273678
Citation
Saez-Llorens X, Yogev R, Arguedas A, Rodriguez A, Spigarelli MG, De Leon Castrejon T, Bomgaars L, Roberts M, Abrams B, Zhou W, Looby M, Kaiser G, Hamed K. Pharmacokinetics and safety of famciclovir in children with herpes simplex or varicella-zoster virus infection. Antimicrob Agents Chemother. 2009 May;53(5):1912-20. doi: 10.1128/AAC.01054-08. Epub 2009 Mar 9.
Results Reference
derived
Learn more about this trial
Famciclovir Oral Pediatric Formulation in Children 1-12 Years of Age With Varicella Zoster Infection
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