NCT00448227

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 16, 2007

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

December 14, 2010

Completed
Last Updated

February 11, 2011

Status Verified

February 1, 2011

Enrollment Period

1.1 years

First QC Date

March 15, 2007

Results QC Date

November 12, 2010

Last Update Submit

February 9, 2011

Conditions

Herpes Simplex

Keywords

Infants, Herpes simplex infection

Outcome Measures

Primary Outcomes (4)

  • Pharmacokinetics of Single Dose - Tmax

    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

    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)

    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)

    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 Outcomes (5)

  • Safety Assessed by AEs, SAEs

    38 days

  • Safety Assessed by Labs

    2 days

  • Tolerability of of the Famciclovir Pediatric Formulation as Assessed by Study Personnel.

    30 minutes after dosing

  • Acceptability of the Famciclovir Pediatric Formulation as Assessed by the Patient's Caregiver

    Immediately after dosing

  • Acceptability of the Famciclovir Pediatric Formulation as Assessed by Study Personnel

    Immediately after dosing

Study Arms (1)

Famciclovir

EXPERIMENTAL

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

Interventions

famciclovirDRUG

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

Also known as: Famvir
Famciclovir

Eligibility Criteria

Age1 Month - 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Pediatric Infectious Disease Of University of Alabama

Birmingham, Alabama, United States

Location

Children's Memorial Hospital Chicago

Chicago, Illinois, United States

Location

Children's Hospital of Michigan

Detroit, Michigan, United States

Location

Archana Chatterjee

Omaha, Nebraska, 68131, United States

Location

University Hospital Cased Medical Center Rainbow Babies and Children's Hospital

Cleveland, Ohio, United States

Location

UT Southwestern Medical Center

Dallas, Texas, United States

Location

Related Publications (1)

  • 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.

    PMID: 20160046DERIVED

Related Links

MeSH Terms

Conditions

Herpes Simplex

Interventions

Famciclovir

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsSkin Diseases, ViralSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

AdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
862-778-8300

Study Officials

  • Novartis

    Novartis

    PRINCIPAL INVESTIGATOR

  • Dr. Jeffery L. Blumer

    University Hospital Cased Medical Center Rainbow Babies and Children's Hospital, Cleveland, OH

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 15, 2007

First Posted

March 16, 2007

Study Start

October 1, 2007

Primary Completion

November 1, 2008

Last Updated

February 11, 2011

Results First Posted

December 14, 2010

Record last verified: 2011-02

Locations

US(6)