Intravesical Cidofovir for Hemorrhagic Cystitis
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|ClinicalTrials.gov Identifier: NCT01816646|
Recruitment Status : Completed
First Posted : March 22, 2013
Last Update Posted : December 6, 2016
The goal of this clinical research study is to learn how the drug cidofovir given as 1 dose directly into the bladder is absorbed by the body. Researchers also want to measure the amount of study drug in the body at different time points. The safety and tolerability of this drug will also be studied.
Cidofovir is designed to fight certain viruses by blocking the virus cells from dividing.
|Condition or disease||Intervention/treatment||Phase|
|Blood And Marrow Transplantation||Drug: Cidofovir Drug: Probenecid||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 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 2013|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
Patients receive a single dose of 2.5 mg/kg of cidofovir administered in 100 ml of normal saline solution through a transurethral catheter inside the bladder. The urinary catheter will be clamped for 2 hours. Probenecid 2 grams by mouth given approximately 3 hours prior to the bladder instillation of cidofovir.
2.5 mg/kg of cidofovir administered in 100 ml of normal saline solution through a transurethral catheter inside the bladder. The urinary catheter will be clamped for 2 hours.
Other Name: Vistide
2 grams by mouth given approximately 3 hours prior to the bladder instillation of cidofovir.
- Systemic Absorption of Cidofovir [ Time Frame: 7 days ]
Systemic absorption of drug evaluated during and after intravesical administration. Blood collected for each sample in the following schedule:
- T0 (pre-instillation)
- 1 hour (after instillation)
- 2 hours (after instillation-at the time of de-clamping)
- 4 hours +/- 1 hour (after instillation)
- 14 hours +/- 1 hour (14 hours after instillation or 12 hours from de-clamping).
- 24 hours +/- 1 hour after instillation to ensure complete characterization of cidofovir elimination.
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): NCT01816646
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Roy F. Chemaly, MD, MPH, MBA||M.D. Anderson Cancer Center|