Famciclovir Pediatric Formulation in Children 1 to 12 Years of Age With Herpes Simplex Infection - Full Text View

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

MedlinePlus related topics:

Fever Herpes Simplex

ChemIDplus related topics:

Famciclovir

U.S. FDA Resources

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 After 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 Outcome Measures:

Step A: single-dose safety and pharmacokinetics
Step B: safety/tolerability of pediatric oral formulation administered 2 times daily over 7 days

Secondary Outcome Measures:

Step A & B: acceptability of pediatric oral formulation by patients

Estimated Enrollment:	76
Study Start Date:	February 2005

Eligibility

Ages Eligible for Study:	1 Year to 12 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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: 1-862-778-3544 or 1-434-951-3228

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00098059

Locations


United States, Alabama
	University of Alabama at Birmingham
	Birmingham, Alabama, United States, 35233-1711

United States, Colorado
	The Children's Hospital
	Denver, Colorado, United States, 80218

United States, Illinois
	Children's Memorial Hospital
	Chicago, Illinois, United States, 60614

United States, Kentucky
	Kosair Charities Pediatric Clinical Research Unit
	Louisville, Kentucky, United States, 40202-3830

United States, New York
	State University of New York at
	Stony Brook, New York, United States, 11794-3362
	Columbia University Medical Center
	New York, New York, United States, 10032

United States, North Carolina
	Duke University Medical Center
	Durham, North Carolina, United States, 27710

United States, Ohio
	University Hospitals of Cleveland
	Cleveland, Ohio, United States, 44106
	Cincinnati Children's Hospital Medical Center
	Cincinnati, Ohio, United States, 45229-3039

United States, Texas
	Baylor College of Medicine/Texas Children's Hospital
	Houston, Texas, United States, 77030
	Children's Medical Center of Dallas
	Dallas, Texas, United States, 75235

Guatemala
	Novartis Investigational Site
	Ciudad de Guatemala, Guatemala

Panama
	Novartis Investigational Site
	Ciudad de Panama, Panama

Panama, Chiriqui
	Novartis Investigational Site
	David, Chiriqui, Panama

Sponsors and Collaborators

Novartis

More Information

Study ID Numbers:	CFAM810B2303
First Received:	December 2, 2004
Last Updated:	December 7, 2007
ClinicalTrials.gov Identifier:	NCT00098059
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

herpes simplex

cold sores

fever blisters

children

Famvir

Study placed in the following topic categories:

Virus Diseases

Fever

Herpes Simplex

Skin Diseases, Infectious

Famciclovir

Skin Diseases

DNA Virus Infections

Blister

Herpesviridae Infections

Herpes Labialis

Additional relevant MeSH terms:

Skin Diseases, Viral

Anti-Infective Agents

Therapeutic Uses

Antiviral Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on July 18, 2008

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