Status:

COMPLETED

A Safety And Tolerability Study Of Valaciclovir Oral Suspension In Infants And Children

Lead Sponsor:

GlaxoSmithKline

Conditions:

Herpes Simplex

Eligibility:

All Genders

1-6 years

Phase:

PHASE1

Brief Summary

Limited data are available on valaciclovir use in children and valaciclovir is not currently approved for use in pediatrics. The marketed formulation of valaciclovir is not ideal for use in pre-adoles...

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • Subjects who have a current herpes virus infection.
  • Have neonatally acquired herpes at risk of potential recurrence.
  • Immunocompromised or cancer patients at risk for development of a herpes virus infection.
  • Exclusion criteria:
  • Hypersensitivity to antiherpetic medications.
  • Impaired hepatic or renal function.
  • Show presence of other serious or unstable underlying disease.

Exclusion

    Key Trial Info

    Start Date :

    January 25 2003

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    February 28 2007

    Estimated Enrollment :

    36 Patients enrolled

    Trial Details

    Trial ID

    NCT00297206

    Start Date

    January 25 2003

    End Date

    February 28 2007

    Last Update

    September 11 2017

    Active Locations (13)

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    Page 1 of 4 (13 locations)

    1

    GSK Investigational Site

    Birmingham, Alabama, United States, 35233

    2

    GSK Investigational Site

    Little Rock, Arkansas, United States, 72202

    3

    GSK Investigational Site

    San Diego, California, United States, 92123

    4

    GSK Investigational Site

    Jacksonville, Florida, United States, 32209