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Completed

NCT Number: NCT00448227

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

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

Completed

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Key information

Conditions

Herpes Simplex DNA Virus Infections Herpesviridae Infections Infections Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Virus Diseases

Age range

1 month–1 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pediatric Infectious Disease Of University of Alabama, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Famciclovir

Drug

Administered orally as a single individualized dose between 25-200 mg based on body weight.

Other names: Famvir

Primary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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:

    • Significant emesis occurred,
    • Infant spit out most of the dose ingesting less than half of what was administered,
    • Infant spit out some of the dose, but ingested at least 50% of what was administered,
    • Infant was able to ingest and retain the dose administered

  4. 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:

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

  5. 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:

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

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
First posted
Mar 16, 2007
Registry last updated
Feb 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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