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

Primary Purpose

Herpes Simplex

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
famciclovir
Sponsored by
Novartis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Herpes Simplex focused on measuring Infants, Herpes simplex infection

Eligibility Criteria

1 Month - 1 Year (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pediatric Infectious Disease Of University of Alabama
  • Children's Memorial Hospital Chicago
  • Children's Hospital of Michigan
  • Archana Chatterjee
  • University Hospital Cased Medical Center Rainbow Babies and Children's Hospital
  • UT Southwestern Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Famciclovir

Arm Description

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.

Outcomes

Primary Outcome Measures

Pharmacokinetics of Single Dose - Tmax
Measured by Tmax - The time after administration of a drug when the maximum plasma concentration is reached.
Pharmacokinetics of Single Dose - Cmax
Measured by Cmax - The maximum plasma concentration of study medication
Pharmacokinetics of Single Dose - AUC(0-tlast)
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)
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
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
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.
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
Acceptability of the Famciclovir Pediatric Formulation as Assessed by the Patient's Caregiver
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
Acceptability of the Famciclovir Pediatric Formulation as Assessed by Study Personnel
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

Full Information

First Posted
March 15, 2007
Last Updated
February 9, 2011
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00448227
Brief Title
Pharmacokinetics, Acceptability and Safety of Famciclovir in Infants (1 Month to Less Than 12 Months) With Herpes Simplex Infection
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Simplex
Keywords
Infants, Herpes simplex infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Famciclovir
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
famciclovir
Other Intervention Name(s)
Famvir
Intervention Description
Administered orally as a single individualized dose between 25-200 mg based on body weight.
Primary Outcome Measure Information:
Title
Pharmacokinetics of Single Dose - Tmax
Description
Measured by Tmax - The time after administration of a drug when the maximum plasma concentration is reached.
Time Frame
Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.
Title
Pharmacokinetics of Single Dose - Cmax
Description
Measured by Cmax - The maximum plasma concentration of study medication
Time Frame
Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.
Title
Pharmacokinetics of Single Dose - AUC(0-tlast)
Description
Measured by AUC(0-tlast) - Area under the plasma concentration time curve from time zero to the last quantifiable concentration-timepoint.
Time Frame
Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.
Title
Pharmacokinetics of Single Dose - AUC(0-6h)
Description
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).
Time Frame
Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.
Secondary Outcome Measure Information:
Title
Safety Assessed by AEs, SAEs
Description
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.
Time Frame
38 days
Title
Safety Assessed by Labs
Description
Samples for safety labs were obtained at baseline and Day 2 visit and samples were analyzed by local accredited laboratory.
Time Frame
2 days
Title
Tolerability of of the Famciclovir Pediatric Formulation as Assessed by Study Personnel.
Description
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
Time Frame
30 minutes after dosing
Title
Acceptability of the Famciclovir Pediatric Formulation as Assessed by the Patient's Caregiver
Description
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
Time Frame
Immediately after dosing
Title
Acceptability of the Famciclovir Pediatric Formulation as Assessed by Study Personnel
Description
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
Time Frame
Immediately after dosing

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis
Organizational Affiliation
Novartis
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dr. Jeffery L. Blumer
Organizational Affiliation
University Hospital Cased Medical Center Rainbow Babies and Children's Hospital, Cleveland, OH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pediatric Infectious Disease Of University of Alabama
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Children's Memorial Hospital Chicago
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Children's Hospital of Michigan
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
Archana Chatterjee
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
University Hospital Cased Medical Center Rainbow Babies and Children's Hospital
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20160046
Citation
Blumer J, Rodriguez A, Sanchez PJ, Sallas W, Kaiser G, Hamed K. Single-dose pharmacokinetics of famciclovir in infants and population pharmacokinetic analysis in infants and children. Antimicrob Agents Chemother. 2010 May;54(5):2032-41. doi: 10.1128/AAC.01508-09. Epub 2010 Feb 16.
Results Reference
derived
Links:
URL
http://www.novartisclinicaltrials.com
Description
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Pharmacokinetics, Acceptability and Safety of Famciclovir in Infants (1 Month to Less Than 12 Months) With Herpes Simplex Infection

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