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

Sponsor:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00098059

Purpose

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.

Condition	Intervention	Phase
Herpes Simplex	Drug: 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 After Administration of Famciclovir Oral Pediatric Formulation to Children 1 to 12 Years of Age With Herpes Simplex Infection

Resource links provided by NLM:

MedlinePlus related topics: Herpes Simplex

Drug Information available for: Famciclovir

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Safety and Tolerability of a Single-Dose of Famciclovir in Part A of the Study. [ Time Frame: 8 hours and 24 hours after study drug administration (Part A) ] [ Designated as safety issue: Yes ]
Maximum Observed Plasma Concentration of Penciclovir (Cmax) [ Time Frame: plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose ] [ Designated as safety issue: No ]
Time of Maximum Observed Plasma Concentration of Penciclovir (Tmax) [ Time Frame: Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose ] [ Designated as safety issue: No ]
Area Under the Penciclovir Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-∞) [ Time Frame: Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose ] [ Designated as safety issue: No ]
Apparent Oral Clearance of Penciclovir (CL/F) [ Time Frame: Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose ] [ Designated as safety issue: No ]
Apparent Terminal Elimination Half-Life of Penciclovir (T1/2) [ Time Frame: Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose ] [ Designated as safety issue: No ]
Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study. [ Time Frame: Administered 2 times daily over 7 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Overall Acceptability of Pediatric Oral Formulation by Patients in Part A of the Study. [ Time Frame: Immediately after dose administration and 2-5 minutes later ] [ Designated as safety issue: No ]
Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study. [ Time Frame: Day 1 at clinic: after swallowing first dose ] [ Designated as safety issue: No ]
Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study [ Time Frame: Day 8 at home: after swallowing last dose ] [ Designated as safety issue: No ]

Enrollment:	74
Study Start Date:	February 2005
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Famciclovir, pediatric oral formulation: Experimental single-arm	Drug: Famciclovir Famciclovir sprinkle capsules, 25 mg and 100 mg, using OraSweet® syrup vehicle

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
Ciudad de David, Chiriqui, Panama

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Sáez-Llorens X, Yogev R, Arguedas A, Rodriguez A, Spigarelli MG, De León Castrejón 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. Epub 2009 Mar 9.

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CFAM810B2303
Study First Received:	December 2, 2004
Results First Received:	February 2, 2009
Last Updated:	May 7, 2009
ClinicalTrials.gov Identifier:	NCT00098059 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

herpes simplex
cold sores
fever blisters
children
Famvir

Additional relevant MeSH terms:

Herpes Simplex
Anti-Infective Agents
Skin Diseases
Infection
Antiviral Agents
Pharmacologic Actions
Herpesviridae Infections

Virus Diseases
Skin Diseases, Viral
Skin Diseases, Infectious
Famciclovir
Therapeutic Uses
DNA Virus Infections

ClinicalTrials.gov processed this record on November 30, 2009