Clinical trial NCT00098059: Famciclovir Pediatric Formulation in Children 1 to 12 Years of Age With Herpes Simplex Infection
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Herpes Simplex
Keywords: herpes simplex
cold sores
fever blisters
children
Famvir
famciclovir
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2004-12-03
Enrollment: 74
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Safety and Tolerability of a Single-dose of Famciclovir in Part A of the Study.
timeFrame: 8 hours and 24 hours after study drug administration (Part A)
measure: Maximum Observed Plasma Concentration of Penciclovir (Cmax)
timeFrame: plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose
measure: Time of Maximum Observed Plasma Concentration of Penciclovir (Tmax)
timeFrame: Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose
measure: Area Under the Penciclovir Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-∞)
timeFrame: Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose
measure: Apparent Oral Clearance of Penciclovir (CL/F)
timeFrame: Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose
measure: Apparent Terminal Elimination Half-life of Penciclovir (T1/2)
timeFrame: Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose
measure: Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study.
timeFrame: Administered 2 times daily over 7 days
Secondary outcomes:
measure: Overall Acceptability of Pediatric Oral Formulation by Patients in Part A of the Study.
timeFrame: Day 1, after swallowing the dose.
measure: Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study.
timeFrame: Day 1 at clinic: after swallowing first dose
measure: Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study
timeFrame: Day 8 at home: after swallowing last dose
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Denver
country: United States
facility: The Children's Hospital
state: Colorado
city: Chicago
country: United States
facility: Children's Memorial Hospital
state: Illinois
city: Louisville
country: United States
facility: Kosair Charities Pediatric Clinical Research Unit
state: Kentucky
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Stony Brook
country: United States
facility: State University of New York at
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Dallas
country: United States
facility: Children's Medical Center of Dallas
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine/Texas Children's Hospital
state: Texas
city: Ciudad de David
country: Panama
facility: Panama Minister of Health
state: Chiriqui
city: Ciudad de Panama
country: Panama
facility: Panama Minister of Health
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
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.