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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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