NCT00098059

Brief Summary

This study will evaluate the safety and blood levels of a new pediatric formulation of Famvir in children 1-12 years of age. In Part A, patients will receive a single dose of famciclovir (12.5 mg/kg) to assess pharmacokinetics (PK) and safety. In Part B, patients will receive multiple doses of famciclovir alone or with concomitant oral anti-herpes therapy to assess safety and tolerability. Part B will start only after PK data from Part A had been analyzed.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2005

Typical duration for phase_3

Geographic Reach
2 countries

13 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

December 2, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 3, 2004

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2005

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

May 6, 2009

Completed
Last Updated

April 25, 2013

Status Verified

April 1, 2013

Enrollment Period

2.8 years

First QC Date

December 2, 2004

Results QC Date

February 2, 2009

Last Update Submit

April 18, 2013

Conditions

Herpes Simplex

Keywords

herpes simplexcold soresfever blisterschildrenFamvirfamciclovir

Outcome Measures

Primary Outcomes (7)

  • Safety and Tolerability of a Single-dose of Famciclovir in Part A of the Study.

    A patient with multiple adverse events (AEs) within the primary system organ class is counted only once in total row.

    8 hours and 24 hours after study drug administration (Part A)

  • Maximum Observed Plasma Concentration of Penciclovir (Cmax)

    PK parameter; penciclovir is the active metabolite of famciclovir.

    plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose

  • Time of Maximum Observed Plasma Concentration of Penciclovir (Tmax)

    PK parameter; penciclovir is the active metabolite of famciclovir.

    Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose

  • Area Under the Penciclovir Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-∞)

    PK parameter; penciclovir is the active metabolite of famciclovir.

    Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose

  • Apparent Oral Clearance of Penciclovir (CL/F)

    PK parameter; penciclovir is the active metabolite of famciclovir.

    Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose

  • Apparent Terminal Elimination Half-life of Penciclovir (T1/2)

    PK parameter; penciclovir is the active metabolite of famciclovir

    Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose

  • Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study.

    A patient with multiple AEs within the primary system organ class is counted only once in total row.

    Administered 2 times daily over 7 days

Secondary Outcomes (3)

  • Overall Acceptability of Pediatric Oral Formulation by Patients in Part A of the Study.

    Day 1, after swallowing the dose.

  • Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study.

    Day 1 at clinic: after swallowing first dose

  • Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study

    Day 8 at home: after swallowing last dose

Study Arms (1)

Famciclovir, pediatric oral formulation

EXPERIMENTAL

single-arm

Drug: Famciclovir

Interventions

FamciclovirDRUG

Famciclovir sprinkle capsules, 25 mg and 100 mg, using OraSweet® syrup vehicle

Famciclovir, pediatric oral formulation

Eligibility Criteria

Age1 Year - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • History or laboratory evidence of herpes simplex infection
  • Clinical evidence or suspicion of herpes simplex infection

You may not qualify if:

  • Patients unable to swallow
  • Concomitant use of probenecid
  • Positive pregnancy test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

University of Alabama at Birmingham

Birmingham, Alabama, 35233-1711, United States

Location

The Children's Hospital

Denver, Colorado, 80218, United States

Location

Children's Memorial Hospital

Chicago, Illinois, 60614, United States

Location

Kosair Charities Pediatric Clinical Research Unit

Louisville, Kentucky, 40202-3830, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

State University of New York at

Stony Brook, New York, 11794-3362, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229-3039, United States

Location

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

Children's Medical Center of Dallas

Dallas, Texas, 75235, United States

Location

Baylor College of Medicine/Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Panama Minister of Health

David, Chiriquí Province, Panama

Location

Panama Minister of Health

Panama City, Panama

Location

Related Publications (1)

  • Saez-Llorens X, Yogev R, Arguedas A, Rodriguez A, Spigarelli MG, De Leon Castrejon T, Bomgaars L, Roberts M, Abrams B, Zhou W, Looby M, Kaiser G, Hamed K. Pharmacokinetics and safety of famciclovir in children with herpes simplex or varicella-zoster virus infection. Antimicrob Agents Chemother. 2009 May;53(5):1912-20. doi: 10.1128/AAC.01054-08. Epub 2009 Mar 9.

    PMID: 19273678DERIVED

MeSH Terms

Conditions

Herpes SimplexHerpes Labialis

Interventions

Famciclovir

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsSkin Diseases, ViralSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue DiseasesLip DiseasesMouth DiseasesStomatognathic 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 Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 2, 2004

First Posted

December 3, 2004

Study Start

February 1, 2005

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

April 25, 2013

Results First Posted

May 6, 2009

Record last verified: 2013-04

Locations

PA(2)US(11)