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

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ClinicalTrials.gov Identifier: NCT00098059
Recruitment Status : Completed
First Posted : December 3, 2004
Results First Posted : May 6, 2009
Last Update Posted : April 25, 2013
Sponsor:
Information provided by:
Novartis

Study Description
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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.

Condition or disease Intervention/treatment Phase
Herpes Simplex Drug: Famciclovir Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : February 2005
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Herpes Simplex
Drug Information available for: Famciclovir

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


Outcome Measures
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Primary Outcome Measures :
  1. 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) ]
    A patient with multiple adverse events (AEs) within the primary system organ class is counted only once in total row.

  2. Maximum Observed Plasma Concentration of Penciclovir (Cmax) [ Time Frame: plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose ]
    PK parameter; penciclovir is the active metabolite of famciclovir.

  3. 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 ]
    PK parameter; penciclovir is the active metabolite of famciclovir.

  4. 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 ]
    PK parameter; penciclovir is the active metabolite of famciclovir.

  5. Apparent Oral Clearance of Penciclovir (CL/F) [ Time Frame: Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose ]
    PK parameter; penciclovir is the active metabolite of famciclovir.

  6. 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 ]
    PK parameter; penciclovir is the active metabolite of famciclovir

  7. Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study. [ Time Frame: Administered 2 times daily over 7 days ]
    A patient with multiple AEs within the primary system organ class is counted only once in total row.


Secondary Outcome Measures :
  1. Overall Acceptability of Pediatric Oral Formulation by Patients in Part A of the Study. [ Time Frame: Day 1, after swallowing the dose. ]
    Overall acceptability of the study medication was determined by caretaker response.

  2. Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study. [ Time Frame: Day 1 at clinic: after swallowing first dose ]
    Overall acceptability of the study medication was determined by caretaker response.

  3. Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study [ Time Frame: Day 8 at home: after swallowing last dose ]
    Overall acceptability of study medication was determined by caretaker response.


Eligibility Criteria
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Ages Eligible for Study:   1 Year to 12 Years   (Child)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00098059


Locations
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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
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00098059    
Other Study ID Numbers: CFAM810B2303
First Posted: December 3, 2004    Key Record Dates
Results First Posted: May 6, 2009
Last Update Posted: April 25, 2013
Last Verified: April 2013
Keywords provided by Novartis:
herpes simplex
cold sores
fever blisters
 children
Famvir
famciclovir
Additional relevant MeSH terms:
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Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
 Famciclovir
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action