Cidofovir Instillation in Hematopoietic Stem Cell Transplant (HSCT) Recipients With Hemorrhagic Cystitis
|ClinicalTrials.gov Identifier: NCT00956176|
Recruitment Status : Withdrawn
First Posted : August 11, 2009
Last Update Posted : September 7, 2012
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.
|Condition or disease||Intervention/treatment|
|Cystitis Bladder Diseases||Drug: Cidofovir|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intravesical Cidofovir Instillation in HSCT Recipients With Hemorrhagic Cystitis: A Single Dose Pharmacokinetic Study|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||September 2014|
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
- Systemic Absorption of Cidofovir via bladder instillation [ Time Frame: Blood collected pre-instillation, 1 hour, 2 hours, 4 hours and 14 hours after instillation. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00956176
|Principal Investigator:||Roy F. Chemaly, MD, MPH, MBA||UT MD Anderson Cancer Center|