Intravesical Cidofovir Instillation in HSCT Recipients With Hemorrhagic Cystitis: A Single Dose Pharmacokinetic Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Systemic Absorption of Cidofovir via bladder instillation
研究概览
简要总结
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.
详细描述
The Study Drug:
Cidofovir is designed to fight CMV (a viral infection) by blocking the CMV cells from dividing.
Cidofovir is commonly given by injection. For research purposes, in this study it will be given directly into the bladder through a foley catheter. This is one of the first studies where cidofovir is being given this way in humans.
Study Drug Administration:
If you are found to be eligible to take part in this study, on Day 1, Cidofovir will be put into your bladder through your foley catheter. The catheter will be clamped for 2 hours to keep the drug in your bladder. After 2 hours, the catheter will be unclamped. If you were receiving bladder irrigation as therapy for your hemorrhagic cystitis, this will be restarted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Polyoma BK or adenovirus viruria has been established either by positive urine cytology or by PCR for BK virus or by positive urine and/or blood culture for adenovirus
- •The patient has either gross hematuria and/or passes blood clots
- •Signed informed consent form
- •Hospitalized patients with a Foley catheter
- •Women of childbearing potential must agree to use 2 acceptable methods of birth control (e. g., abstinence, IUD, or barrier method), during the study period and one for a period of 2 months afterward. At least one of the methods must be a barrier method. Males must also agree to use acceptable method of birth control (barrier method) during the study period and for 2 months afterward.
排除标准
- •Serum creatinine >1.5 mg/dl and/or calculated creatinine clearance < 55 ml/min using the Cockcroft-Gault Creatinine Clearance formula (CrCl). CrCl = {(140-Age) x Weight (kgs) x 0.85 (if female)}/ {72x Serum Creatinine (mg/dl)}
- •Urine protein > 100 mg/dl (equivalent to > 2+ proteinuria)
- •Age less than 18 years
- •Prior therapy with formalin or carboprost 1 mg % administered intravesically
- •Hypersensitivity to cidofovir, probenecid or sulfa-containing medications
- •Have received prior cidofovir therapy within 2 weeks.
- •Prior enrollment in the study
- •Women who are pregnant or breast-feeding
- •Evidence of end-organ adenoviral infection
研究组 & 干预措施
Cidofovir
干预措施: Cidofovir (Drug)
结局指标
主要结局
Systemic Absorption of Cidofovir via bladder instillation
时间窗: Blood collected pre-instillation, 1 hour, 2 hours, 4 hours and 14 hours after instillation.
次要结局
未报告次要终点