Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00042328
Status:
COMPLETED
Last Update Posted:
2015-08-24
First Post:
2002-07-26
Brief Title:
A Pharmacokinetic Study of Valacyclovir in Pediatric Oncology Patients
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
A Pharmacokinetic Study of Valacyclovir in Pediatric Oncology Patients
Status:
COMPLETED
Status Verified Date:
2015-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research is to study the pharmacology how the body handles this drug of valacyclovir in children receiving treatment for cancer This study will last approximately 7 days
Detailed Description:
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 05 1 15 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| VALACYCLOVIR SINGLE DOSE | None | None | None |