A Pharmacokinetic Study of Valacyclovir in Pediatric Oncology Patients
In this study, patients will receive a single dose of oral valacyclovir. Blood samples will
be drawn to evaluate the pharmacology (how the body handles the drug). Blood samples (less
than one teaspoon each) will be obtained before receiving the drug and at 0.5, 1, 1.5, 2,
5, 6, and 8 hours after receiving the drug. The total amount of blood drawn from patients
for all blood work including routine blood tests as well as pharmacokinetics will not be
greater than 5% of the total blood volume.
We will also have all urine output collected for 8 hours starting at the time patients
receive the dose of valacyclovir. A 5cc sample of urine will be collected and analyzed to
determine how the body handles the drug at hours 2, 4, 6, and 8.
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Susan Blaney, MD
Texas Children's Hospital
United States: Food and Drug Administration
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