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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00448227
First received: March 15, 2007
Last updated: February 9, 2011
Last verified: February 2011
  Purpose

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


Condition Intervention Phase
Herpes Simplex
Drug: famciclovir
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Pharmacokinetics of Single Dose - Tmax [ Time Frame: Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing. ] [ Designated as safety issue: No ]
    Measured by Tmax - The time after administration of a drug when the maximum plasma concentration is reached.

  • Pharmacokinetics of Single Dose - Cmax [ Time Frame: Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing. ] [ Designated as safety issue: No ]
    Measured by Cmax - The maximum plasma concentration of study medication

  • Pharmacokinetics of Single Dose - AUC(0-tlast) [ Time Frame: Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing. ] [ Designated as safety issue: No ]
    Measured by AUC(0-tlast) - Area under the plasma concentration time curve from time zero to the last quantifiable concentration-timepoint.

  • Pharmacokinetics of Single Dose - AUC(0-6h) [ Time Frame: Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing. ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Safety Assessed by AEs, SAEs [ Time Frame: 38 days ] [ Designated as safety issue: No ]
    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.

  • Safety Assessed by Labs [ Time Frame: 2 days ] [ Designated as safety issue: No ]
    Samples for safety labs were obtained at baseline and Day 2 visit and samples were analyzed by local accredited laboratory.

  • Tolerability of of the Famciclovir Pediatric Formulation as Assessed by Study Personnel. [ Time Frame: 30 minutes after dosing ] [ Designated as safety issue: No ]

    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

  • Acceptability of the Famciclovir Pediatric Formulation as Assessed by the Patient's Caregiver [ Time Frame: Immediately after dosing ] [ Designated as safety issue: No ]

    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

  • Acceptability of the Famciclovir Pediatric Formulation as Assessed by Study Personnel [ Time Frame: Immediately after dosing ] [ Designated as safety issue: No ]

    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


Enrollment: 18
Study Start Date: October 2007
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Famvir

  Eligibility

Ages Eligible for Study:   1 Month to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00448227

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

Additional Information:
No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00448227     History of Changes
Other Study ID Numbers: CFAM810B2301
Study First Received: March 15, 2007
Results First Received: November 12, 2010
Last Updated: February 9, 2011
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Guatemala: Ministry of Health Commission for Clinical Trials Evaluation

Keywords provided by Novartis:
Infants, Herpes simplex infection

Additional relevant MeSH terms:
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Famciclovir
2-Aminopurine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014