Pharmacokinetics, Acceptability and Safety of Famciclovir in Infants (1 Month to Less Than 12 Months) With Herpes Simplex Infection

February 9, 2011 updated by: Novartis

A Multicenter, Open-label, Single-arm Study to Evaluate the Single-dose Pharmacokinetics, Acceptability and Safety of Famciclovir Oral Pediatric Formulation in Infants 1 Month to Less Than 1 Year of Age With Herpes Simplex Virus Infections

This study will evaluate the acceptability and safety of famciclovir in infants with herpes simplex infection

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 2

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

  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • Pediatric Infectious Disease Of University of Alabama
    • Illinois
      • Chicago, Illinois, United States
        • Children's Memorial Hospital Chicago
    • Michigan
      • Detroit, Michigan, United States
        • Children's Hospital of Michigan
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Archana Chatterjee
    • Ohio
      • Cleveland, Ohio, United States
        • University Hospital Cased Medical Center Rainbow Babies and Children's Hospital
    • Texas
      • Dallas, Texas, United States
        • UT Southwestern Medical Center

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 month to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female patients from 1 month up to 1 year of age with herpes simplex infection

Exclusion Criteria:

  • Patients with gestational age less than 32 weeks. Patients unable to swallow. Patients with history of malabsorption or previous gastrointestinal surgery.

Other protocol-defined inclusion/exclusion criteria may apply.

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Famciclovir
Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
Drug: famciclovir
Administered orally as a single individualized dose between 25-200 mg based on body weight.
Other Names:
  • Famvir

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics of Single Dose - Tmax
Time Frame: Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.
Measured by Tmax - The time after administration of a drug when the maximum plasma concentration is reached.
Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.
Pharmacokinetics of Single Dose - Cmax
Time Frame: Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.
Measured by Cmax - The maximum plasma concentration of study medication
Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.
Pharmacokinetics of Single Dose - AUC(0-tlast)
Time Frame: Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.
Measured by AUC(0-tlast) - Area under the plasma concentration time curve from time zero to the last quantifiable concentration-timepoint.
Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.
Pharmacokinetics of Single Dose - AUC(0-6h)
Time Frame: Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.
Measured by AUC(0-6h) - Area under the plasma concentration time curve from time zero up to 6 hours post dose (i.e. the time of the last sample).
Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety Assessed by AEs, SAEs
Time Frame: 38 days
AEs and SAEs were collected during patient's stay in the clinic for PK sampling up to Hour 8, then at day 2 visit, 8 days(safety follow-up call) and 38 days (safety follow-up call) post dose.
38 days
Safety Assessed by Labs
Time Frame: 2 days
Samples for safety labs were obtained at baseline and Day 2 visit and samples were analyzed by local accredited laboratory.
2 days
Tolerability of of the Famciclovir Pediatric Formulation as Assessed by Study Personnel.
Time Frame: 30 minutes after dosing

Tolerability was assessed by the study personnel 30 minutes after dosing using the following scale:

  1. Significant emesis occurred,
  2. Infant spit out most of the dose ingesting less than half of what was administered,
  3. Infant spit out some of the dose, but ingested at least 50% of what was administered,
  4. Infant was able to ingest and retain the dose administered
30 minutes after dosing
Acceptability of the Famciclovir Pediatric Formulation as Assessed by the Patient's Caregiver
Time Frame: Immediately after dosing

Assessed by the caregiver using a 5-point scale immediately after dosing:

  1. Very badly accepted/unacceptable: infant showed great displeasure, compromising use of formulation
  2. Badly but accepted: infant showed displeasure with dosing but could be coaxed to take complete dose
  3. Neither good nor bad: infant showed no apparent displeasure and with little effort was coaxed to take complete dose
  4. Well accepted: infant appeared to enjoy the formulation and with little coaxing ingested most of dose
  5. Very well accepted: infant appeared eager and ingested most of dose without special coaxing
Immediately after dosing
Acceptability of the Famciclovir Pediatric Formulation as Assessed by Study Personnel
Time Frame: Immediately after dosing

Assessed by the study personnel using a 5-point scale after dosing:

  1. Very badly accepted/unacceptable: infant showed great displeasure, compromising use of formulation
  2. Badly but accepted: infant showed displeasure with dosing but could be coaxed to take complete dose
  3. Neither good nor bad: infant showed no apparent displeasure and with little effort was coaxed to take complete dose
  4. Well accepted: infant appeared to enjoy the formulation and with little coaxing ingested most of dose
  5. Very well accepted: infant appeared eager and ingested most of dose without special coaxing
Immediately after dosing

Collaborators and Investigators

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

Sponsor

Novartis

Investigators

  • Principal Investigator: Novartis, Novartis
  • Principal Investigator: Dr. Jeffery L. Blumer, University Hospital Cased Medical Center Rainbow Babies and Children's Hospital, Cleveland, OH

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

Helpful Links

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

October 1, 2007

Primary Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

March 15, 2007

First Submitted That Met QC Criteria

March 15, 2007

First Posted (Estimate)

March 16, 2007

Study Record Updates

Last Update Posted (Estimate)

February 11, 2011

Last Update Submitted That Met QC Criteria

February 9, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CFAM810B2301

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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