Cidofovir Instillation in Hematopoietic Stem Cell Transplant (HSCT) Recipients With Hemorrhagic Cystitis
The goal of this clinical research study is to learn how the body absorbs and processes 1 dose of cidofovir that is given directly into the bladder, in patients with a viral infection that is causing bleeding from the bladder.
The safety of this drug dose and the investigational way it is given (directly into the bladder) will also be studied.
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Intravesical Cidofovir Instillation in HSCT Recipients With Hemorrhagic Cystitis: A Single Dose Pharmacokinetic Study|
- Systemic Absorption of Cidofovir via bladder instillation [ Time Frame: Blood collected pre-instillation, 1 hour, 2 hours, 4 hours and 14 hours after instillation. ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2012|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Single dose of 5 mg/kg administered in 100 ml of normal saline solution through a foley catheter to bladder. The catheter will be clamped for 2 hours to keep the drug in bladder.
Other Name: Vistide
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00956176
|Principal Investigator:||Roy F. Chemaly, MD, MPH, MBA||UT MD Anderson Cancer Center|