A Safety And Tolerability Study Of Valaciclovir Oral Suspension In Infants And Children
An Open-label, Single-dose, Multicenter, Pharmacokinetic, Safety and Tolerability Study of Valaciclovir Oral Suspension in Infants and Children.
1 other identifier
interventional
36
3 countries
13
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-adolescent patients who may have trouble swallowing solid oral dosage forms. An extemporaneous suspension formulation of valaciclovir has been developed to expedite the provision of benefits to children similar to those from administration of valaciclovir solid formulations in adults.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jan 2003
Longer than P75 for phase_1
13 active sites
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
Study Start
First participant enrolled
January 25, 2003
CompletedFirst Submitted
Initial submission to the registry
February 24, 2006
CompletedFirst Posted
Study publicly available on registry
February 28, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2007
CompletedSeptember 11, 2017
September 1, 2017
4.1 years
February 24, 2006
September 8, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Plasma acyclovir and valaciclovir concentrations pre-dose (within 15 minutes of dose administration) and at 0.5, 1, 2, 4 and 6 hours following administration of the valaciclovir oral suspension dose.
0.5, 1, 2, 4 and 6 hours
Secondary Outcomes (1)
Safety monitoring throughout the study and at the follow up evaluation 2-4 days after the single dose of study medication.
Up to Day 5
Study Arms (5)
Cohort 1
EXPERIMENTALSubjects in the age group of 2 to less than 6 years will be included
Cohort 2
EXPERIMENTALSubjects in the age group of 1 to less than 2 years will be included
Cohort 3
EXPERIMENTALSubjects in the age group of 6 months to less than 1 year will be included
Cohort 4
EXPERIMENTALSubjects in the age group of 3 months to less than 6 months will be included
Cohort 5
EXPERIMENTALSubjects in the age group of 1 month to less than 3 months will be included
Interventions
Valaciclovir will be administered as an extemporaneously prepared suspension formulation. Valaciclovir oral suspension will be prepared by crushing marketed Valtrex Caplets 500 milligram (mg) and suspending the resultant powder in Suspension Structured Vehicle USNF with dose strength of 25 milligram per milliliter (mg/mL) or 50 mg/mL.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Hypersensitivity to antiherpetic medications.
- Impaired hepatic or renal function.
- Show presence of other serious or unstable underlying disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (13)
GSK Investigational Site
Birmingham, Alabama, 35233, United States
GSK Investigational Site
Little Rock, Arkansas, 72202, United States
GSK Investigational Site
San Diego, California, 92123, United States
GSK Investigational Site
Jacksonville, Florida, 32209, United States
GSK Investigational Site
Lexington, Kentucky, 40503, United States
GSK Investigational Site
Louisville, Kentucky, 40202, United States
GSK Investigational Site
New Orleans, Louisiana, 70112, United States
GSK Investigational Site
Durham, North Carolina, 27705, United States
GSK Investigational Site
Cincinnati, Ohio, 45229, United States
GSK Investigational Site
Galveston, Texas, 77555-0653, United States
GSK Investigational Site
Santiago, Región Metro de Santiago, 7580206, Chile
GSK Investigational Site
Brits, 2000, South Africa
GSK Investigational Site
George, 6529, South Africa
Related Publications (2)
Bradley J, Scholtz F, Brennan C, Zhao H, Weller S. Pharmacokinetics and safety of single-dose valacyclovir oral suspension in infants and children with current or potential herpesvirus infection. Poster presentation, 45th Annual Meeting Infectious Disease
BACKGROUNDKimberlin DW, Jacobs RF, Weller S, van der Walt JS, Heitman CK, Man CY, Bradley JS. Pharmacokinetics and safety of extemporaneously compounded valacyclovir oral suspension in pediatric patients from 1 month through 11 years of age. Clin Infect Dis. 2010 Jan 15;50(2):221-8. doi: 10.1086/649212.
PMID: 20014952BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2006
First Posted
February 28, 2006
Study Start
January 25, 2003
Primary Completion
February 28, 2007
Study Completion
February 28, 2007
Last Updated
September 11, 2017
Record last verified: 2017-09
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.