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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT00297206 |
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Date of registration:
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24/02/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Safety And Tolerability Study Of Valaciclovir Oral Suspension In Infants And Children
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Scientific title:
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An Open-label, Single-dose, Multicenter, Pharmacokinetic, Safety and Tolerability Study of Valaciclovir Oral Suspension in Infants and Children. |
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Date of first enrolment:
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January 25, 2003 |
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Target sample size:
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36 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00297206 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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Argentina
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Chile
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South Africa
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Sweden
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United States
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Contacts
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Name:
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GSK Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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GlaxoSmithKline |
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Key inclusion & exclusion criteria
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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.
Age minimum:
1 Month
Age maximum:
6 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Herpes Simplex
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Intervention(s)
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Drug: Valaciclovir
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Primary Outcome(s)
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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.
[Time Frame: 0.5, 1, 2, 4 and 6 hours]
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Secondary Outcome(s)
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Safety monitoring throughout the study and at the follow up evaluation 2-4 days after the single dose of study medication.
[Time Frame: Up to Day 5]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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