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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00098059
First received: December 2, 2004
Last updated: April 18, 2013
Last verified: April 2013
  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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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:


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: No ]
    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) [ Time Frame: plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose ] [ Designated as safety issue: No ]
    PK parameter; penciclovir is the active metabolite of famciclovir.

  • 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 ]
    PK parameter; penciclovir is the active metabolite of famciclovir.

  • 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 ]
    PK parameter; penciclovir is the active metabolite of famciclovir.

  • 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 ]
    PK parameter; penciclovir is the active metabolite of famciclovir.

  • 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 ]
    PK parameter; penciclovir is the active metabolite of famciclovir

  • 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: No ]
    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. [ Time Frame: Day 1, after swallowing the dose. ] [ Designated as safety issue: No ]
    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. [ Time Frame: Day 1 at clinic: after swallowing first dose ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 8 at home: after swallowing last dose ] [ Designated as safety issue: No ]
    Overall acceptability of study medication was determined by caretaker response.


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
Experimental: Famciclovir, pediatric oral formulation
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Columbia University Medical Center
New York, New York, United States, 10032
State University of New York at
Stony Brook, New York, United States, 11794-3362
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3039
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
United States, Texas
Children's Medical Center of Dallas
Dallas, Texas, United States, 75235
Baylor College of Medicine/Texas Children's Hospital
Houston, Texas, United States, 77030
Panama
Panama Minister of Health
Ciudad de David, Chiriqui, Panama
Panama Minister of Health
Ciudad de Panama, Panama
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00098059     History of Changes
Other Study ID Numbers: CFAM810B2303
Study First Received: December 2, 2004
Results First Received: February 2, 2009
Last Updated: April 18, 2013
Health Authority: United States: Food and Drug Administration
Panama Minister of Health: Panama

Keywords provided by Novartis:
herpes simplex
cold sores
fever blisters
children
Famvir
famciclovir

Additional relevant MeSH terms:
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Famciclovir
2-Aminopurine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014