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

December 2, 2004
April 18, 2013
February 2005
December 2007   (final data collection date for primary outcome measure)
  • 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.
  • Safety
  • Blood levels
Complete list of historical versions of study NCT00098059 on ClinicalTrials.gov Archive Site
  • 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.
Not Provided
Not Provided
Not Provided
 
Famciclovir Pediatric Formulation in Children 1 to 12 Years of Age With Herpes Simplex Infection
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

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Herpes Simplex
Drug: Famciclovir
Famciclovir sprinkle capsules, 25 mg and 100 mg, using OraSweet® syrup vehicle
Experimental: Famciclovir, pediatric oral formulation
single-arm
Intervention: Drug: Famciclovir
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
74
December 2007
December 2007   (final data collection date for primary outcome measure)

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

Both
1 Year to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Panama
 
NCT00098059
CFAM810B2303
Not Provided
External Affairs, Novartis Pharmaceuticals
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP