Last updated: 11/04/2018 08:11:37

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

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GSK study ID
HS210914
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Clinicaltrials.gov ID
NCT00297206
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: An open-label, single-dose, multicenter, pharmacokinetic, safety and tolerability study of valaciclovir oral suspension in infants and children.
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

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.

Timeframe: 0.5, 1, 2, 4 and 6 hours

Secondary outcomes:

Safety monitoring throughout the study and at the follow up evaluation 2-4 days after the single dose of study medication.

Timeframe: Up to Day 5

Interventions:
  • Drug: Valaciclovir
    • Enrollment:
    36
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    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
    Kimberlin 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; 50(2):221-8
    Medical condition
    Herpes Simplex
    Product
    valaciclovir
    Collaborators
    Not applicable
    Study date(s)
    January 2003 to February 2007
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    1 months - 6 years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Subjects who have a current herpes virus infection.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • 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.

    Trial location(s)

    Location
    Status
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    Location
    GSK Investigational Site
    Little Rock, Arkansas, United States, 72202
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Santiago, Región Metro De Santiago, Chile, 7580206
    Status
    Study Complete
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    Location
    GSK Investigational Site
    George, South Africa, 6529
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Galveston, Texas, United States, 77555-0653
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Durham, North Carolina, United States, 27705
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Brits, South Africa, 2000
    Status
    Study Complete
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    Showing 1 - 6 of 13 Results

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2007-28-02

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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    Additional information
    Results for study HS210914 can be found on the GSK Clinical Study Register.
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