Cidofovir Instillation in Hematopoietic Stem Cell Transplant (HSCT) Recipients With Hemorrhagic Cystitis
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|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Recruitment Status : Withdrawn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||Phase|
|Cystitis Bladder Diseases||Drug: Cidofovir||Not Applicable|
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. ]
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): NCT00956176
|Principal Investigator:||Roy F. Chemaly, MD, MPH, MBA||UT MD Anderson Cancer Center|