A Pharmacokinetic Study of Valacyclovir in Pediatric Oncology Patients
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|ClinicalTrials.gov Identifier: NCT00042328|
Recruitment Status : Completed
First Posted : August 1, 2002
Last Update Posted : August 24, 2015
|Condition or disease||Intervention/treatment||Phase|
|Neoplasms||Drug: Valacyclovir||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pharmacokinetic Study of Valacyclovir in Pediatric Oncology Patients|
|Study Start Date :||August 2001|
|Actual Primary Completion Date :||May 2005|
|Actual Study Completion Date :||May 2005|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00042328
|United States, Texas|
|Texas Children's Hospital|
|Houston, Texas, United States|
|Principal Investigator:||Susan Blaney, MD||Texas Children's Hospital|