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

Primary Purpose

Herpes Simplex

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Famciclovir
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Herpes Simplex focused on measuring herpes simplex, cold sores, fever blisters, children, Famvir, famciclovir

Eligibility Criteria

1 Year - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham
  • The Children's Hospital
  • Children's Memorial Hospital
  • Kosair Charities Pediatric Clinical Research Unit
  • Columbia University Medical Center
  • State University of New York at
  • Duke University Medical Center
  • Cincinnati Children's Hospital Medical Center
  • University Hospitals of Cleveland
  • Children's Medical Center of Dallas
  • Baylor College of Medicine/Texas Children's Hospital
  • Panama Minister of Health
  • Panama Minister of Health

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Famciclovir, pediatric oral formulation

Arm Description

single-arm

Outcomes

Primary Outcome Measures

Safety and Tolerability of a Single-dose of Famciclovir in Part A of the Study.
A patient with multiple adverse events (AEs) within the primary system organ class is counted only once in total row.
Maximum Observed Plasma Concentration of Penciclovir (Cmax)
PK parameter; penciclovir is the active metabolite of famciclovir.
Time of Maximum Observed Plasma Concentration of Penciclovir (Tmax)
PK parameter; penciclovir is the active metabolite of famciclovir.
Area Under the Penciclovir Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-∞)
PK parameter; penciclovir is the active metabolite of famciclovir.
Apparent Oral Clearance of Penciclovir (CL/F)
PK parameter; penciclovir is the active metabolite of famciclovir.
Apparent Terminal Elimination Half-life of Penciclovir (T1/2)
PK parameter; penciclovir is the active metabolite of famciclovir
Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study.
A patient with multiple AEs within the primary system organ class is counted only once in total row.

Secondary Outcome Measures

Overall Acceptability of Pediatric Oral Formulation by Patients in Part A of the Study.
Overall acceptability of the study medication was determined by caretaker response.
Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study.
Overall acceptability of the study medication was determined by caretaker response.
Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study
Overall acceptability of study medication was determined by caretaker response.

Full Information

First Posted
December 2, 2004
Last Updated
April 18, 2013
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00098059
Brief Title
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

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Simplex
Keywords
herpes simplex, cold sores, fever blisters, children, Famvir, famciclovir

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Famciclovir, pediatric oral formulation
Arm Type
Experimental
Arm Description
single-arm
Intervention Type
Drug
Intervention Name(s)
Famciclovir
Intervention Description
Famciclovir sprinkle capsules, 25 mg and 100 mg, using OraSweet® syrup vehicle
Primary Outcome Measure Information:
Title
Safety and Tolerability of a Single-dose of Famciclovir in Part A of the Study.
Description
A patient with multiple adverse events (AEs) within the primary system organ class is counted only once in total row.
Time Frame
8 hours and 24 hours after study drug administration (Part A)
Title
Maximum Observed Plasma Concentration of Penciclovir (Cmax)
Description
PK parameter; penciclovir is the active metabolite of famciclovir.
Time Frame
plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose
Title
Time of Maximum Observed Plasma Concentration of Penciclovir (Tmax)
Description
PK parameter; penciclovir is the active metabolite of famciclovir.
Time Frame
Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose
Title
Area Under the Penciclovir Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-∞)
Description
PK parameter; penciclovir is the active metabolite of famciclovir.
Time Frame
Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose
Title
Apparent Oral Clearance of Penciclovir (CL/F)
Description
PK parameter; penciclovir is the active metabolite of famciclovir.
Time Frame
Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose
Title
Apparent Terminal Elimination Half-life of Penciclovir (T1/2)
Description
PK parameter; penciclovir is the active metabolite of famciclovir
Time Frame
Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose
Title
Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study.
Description
A patient with multiple AEs within the primary system organ class is counted only once in total row.
Time Frame
Administered 2 times daily over 7 days
Secondary Outcome Measure Information:
Title
Overall Acceptability of Pediatric Oral Formulation by Patients in Part A of the Study.
Description
Overall acceptability of the study medication was determined by caretaker response.
Time Frame
Day 1, after swallowing the dose.
Title
Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study.
Description
Overall acceptability of the study medication was determined by caretaker response.
Time Frame
Day 1 at clinic: after swallowing first dose
Title
Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study
Description
Overall acceptability of study medication was determined by caretaker response.
Time Frame
Day 8 at home: after swallowing last dose

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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233-1711
Country
United States
Facility Name
The Children's Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Children's Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Facility Name
Kosair Charities Pediatric Clinical Research Unit
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202-3830
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
State University of New York at
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-3362
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229-3039
Country
United States
Facility Name
University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Children's Medical Center of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Baylor College of Medicine/Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Panama Minister of Health
City
Ciudad de David
State/Province
Chiriqui
Country
Panama
Facility Name
Panama Minister of Health
City
Ciudad de Panama
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

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

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