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Famciclovir Oral Pediatric Formulation in Children 1-12 Years of Age With Varicella Zoster Infection

NCT ID: NCT00098046

Last Updated: 2007-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2007-07-31

Brief Summary

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Varicella zoster virus causes chickenpox in children and shingles in adults. Chickenpox is usually a self-limiting illness characterized by fever and a rash. Serious complications can include secondary bacterial infections, pneumonia, and encephalitis. Anti-viral treatment is not a standard of care in immunocompetent children, but is recommended whenever a risk of complication exists. This study will evaluate the safety and blood levels of a new formulation of famciclovir in children 1-12 years of age.

Detailed Description

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Conditions

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Chickenpox Herpes Zoster

Keywords

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chickenpox herpes zoster children Famvir varicella zoster virus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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famciclovir

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female children 1-12 years of age
* Clinical or laboratory evidence of varicella zoster infection
* Patients suspected of having varicella zoster infection

Exclusion Criteria

* Patients unable to swallow
* Concomitant use of probenecid
* Positive pregnancy
Minimum Eligible Age

1 Year

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_CHAIR

Novartis Pharmaceuticals

Locations

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Columbia University Medical Center

New York, New York, United States

Site Status

Novartis Investigational Site

San José, , Costa Rica

Site Status

Novartis Investigational Site

Cuidad de Guatemala, , Guatemala

Site Status

Novartis Investigational Site

David, Chiriqui, , Panama

Site Status

Novartis Investigational Site

Panama City, , Panama

Site Status

Countries

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United States Costa Rica Guatemala Panama

References

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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.

Reference Type DERIVED
PMID: 19273678 (View on PubMed)

Other Identifiers

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CFAM810B2304

Identifier Type: -

Identifier Source: org_study_id