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

This study is currently recruiting patients

Verified by Novartis August 2006

Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00098059


Purpose

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.


Condition Intervention Phase
Herpes Simplex Drug: Famvir (famciclovir) Phase III

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

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 Afer Administration of Famciclovir Oral Pediatric Formulation to Children 1 to 12 Years of Age With Herpes Simplex Infection

Further study details as provided by Novartis:
Primary Outcomes: Step A: single-dose safety and pharmacokinetics; Step B: safety/tolerability of pediatric oral formulation administered 2 times daily over 7 days
Secondary Outcomes: Step A & B: acceptability of pediatric oral formulation by patients
Expected Total Enrollment:  76

Study start: February 2005

Eligibility

Ages Eligible for Study:  1 Year   -   12 Years,  Genders Eligible for Study:  Both
Criteria

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: 1-862-778-5788 or 1-434-951-3228

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00098059

Susan Carty, MSN, ARNP, CCRC, CCRA      913 410 2164    cartysusan@PRAIntl.com

Alabama
University of Alabama at Birmingham, Birmingham,  Alabama,  35233-1711,  United States; Recruiting
David Kimberlin, MD  205-996-6097    dkimberlin@peds.uab.edu 

California
Children’s Hospital of San Diego, San Diego,  California,  92123,  United States; Recruiting
John Bradley, MD  858-966-7785    jbradley@chsd.org 

Colorado
The Children's Hospital, Denver,  Colorado,  80218,  United States; Recruiting
Roger Giller, MD  303-764-8563    giller.roger@tchden.org 

Illinois
Children’s Memorial Hospital, Chicago,  Illinois,  60614,  United States; Recruiting
Ram Yogev, MD  773-880-4757    ryogev@childrensmemorial.org 

Kentucky
Kosair Charities Pediatric Clinical Research Unit, Louisville,  Kentucky,  40202-3830,  United States; Recruiting
Amanda Myers, MD  502-629-5820    abmyer01@louisville.edu 

New York
State University of New York at, Stony Brook,  New York,  11794-3362,  United States; Recruiting
Sharon Nachman, MD  631-444-9016    sharon.nachman@sunysb.edu 

Columbia University Medical Center, New York,  New York,  10032,  United States; Recruiting
Natalie Neu, MD  212-305-9683    nn45@columbia.edu 

North Carolina
Duke University Medical Center, Durham,  North Carolina,  27710,  United States; Recruiting
Coleen Cunningham, MD  919-668-6335    coleen.cunningham@duke.edu 

Ohio
University Hospitals of Cleveland, Cleveland,  Ohio,  44106,  United States; Recruiting
Jeffrey Blumer, MD  216-844-3310    jxb53@cwru.edu 

Cincinnati Children's Hospital Medical Center, Cincinnati,  Ohio,  45229-3039,  United States; Recruiting
Michael Gerber, MD  513-636-4578    michael.gerber@cchmc.org 

Texas
Baylor College of Medicine/Texas Children's Hospital, Houston,  Texas,  77030,  United States; Recruiting
Lisa Bomgaars, MD  832-824-4589    lbomgaars@txccc.org 

Children's Medical Center of Dallas, Dallas,  Texas,  75235,  United States; Not yet recruiting
Hasan S Jafri, MD  214-648-3720    hasan.jafri@utsouthwestern.edu 

More Information

Study ID Numbers:  CFAM810B2303
Last Updated:  August 23, 2006
Record first received:  December 2, 2004
ClinicalTrials.gov Identifier:  NCT00098059
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-10-02





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