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

April 18, 2013 updated by: Novartis Pharmaceuticals

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Panama
      • Ciudad de Panama, Panama
        • Panama Minister of Health
    • Chiriqui
      • Ciudad de David, Chiriqui, Panama
        • Panama Minister of Health
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233-1711
        • University of Alabama at Birmingham
    • Colorado
      • Denver, Colorado, United States, 80218
        • The Children's Hospital
    • Illinois
      • Chicago, Illinois, United States, 60614
        • Children's Memorial Hospital
    • Kentucky
      • Louisville, Kentucky, United States, 40202-3830
        • Kosair Charities Pediatric Clinical Research Unit
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • Stony Brook, New York, United States, 11794-3362
        • State University of New York at
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45229-3039
        • Cincinnati Children's Hospital Medical Center
      • Cleveland, Ohio, United States, 44106
        • University Hospitals of Cleveland
    • Texas
      • Dallas, Texas, United States, 75235
        • Children's Medical Center of Dallas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine/Texas Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 12 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Famciclovir, pediatric oral formulation
single-arm
Drug: Famciclovir
Famciclovir sprinkle capsules, 25 mg and 100 mg, using OraSweet® syrup vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 hours and 24 hours after study drug administration (Part A)
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.
plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose
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.
Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose
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.
Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose
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.
Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose
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
Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose
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.
Administered 2 times daily over 7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1, after swallowing the dose.
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.
Day 1 at clinic: after swallowing first dose
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.
Day 8 at home: after swallowing last dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Primary Completion (ACTUAL)

December 1, 2007

Study Completion (ACTUAL)

December 1, 2007

Study Registration Dates

First Submitted

December 2, 2004

First Submitted That Met QC Criteria

December 2, 2004

First Posted (ESTIMATE)

December 3, 2004

Study Record Updates

Last Update Posted (ESTIMATE)

April 25, 2013

Last Update Submitted That Met QC Criteria

April 18, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CFAM810B2303

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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