Intravesical Cidofovir Instillation in HSCT Recipients With Hemorrhagic Cystitis: A Single Dose Pharmacokinetic Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Systemic Absorption of Cidofovir
研究概览
简要总结
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.
详细描述
Study Drug Administration:
If you are found to be eligible to take part in this study, on Day 1, you may receive some fluid for hydration by vein and then cidofovir will be put into your bladder through your foley catheter. The catheter will be clamped shut for 2 hours to keep the drug inside your bladder. After 2 hours, the catheter will be unclamped so that the drug may drain out. If you were receiving bladder irrigation (where the bladder is flushed with water) as therapy for hemorrhagic cystitis, this therapy will be restarted after your dose of cidofovir.
Pharmacokinetic (PK) Testing:
On Day 1, blood (about 2 teaspoons each time) will be drawn for PK testing approximately 1 hour (+/- 15 minutes) before the dose, and then again at 1 hour (+/- 15 minutes), 2 hours (+/- 15 minutes), 4 hours (+/- 1 hour), 14 hours (+/- 1 hour) and 24 hours (+/- 1 hour) after the dose. A PK sample will also be drawn on Day 14 (+- 2 days) after the dose. PK testing measures the amount of study drug in the body at different time points.
Virus Testing:
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 culture for adenovirus.
- •The patient has either gross hematuria and/or passes blood clots.
- •Signed informed consent form containing all potential serious adverse events related to cidofovir use as given on the package insert.
- •Hospitalized patients with a Foley catheter.
- •Women of childbearing potential (Women who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy) must agree to use 2 acceptable methods of birth control (e. g., barrier method (such and condom or diaphragm) and another form, such as an intrauterine device (IUD) or hormonal birth control, during the study period and for a period of 2 months afterward. Males must also agree to use an acceptable method of birth control (barrier method) during the study period and for 2 months afterward.
排除标准
- •Serum creatinine >2 mg/dl and/or calculated creatinine clearance < 50 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/dL administered intravesically.
- •Hypersensitivity to cidofovir, probenecid or sulfa-containing medications
- •Patients who 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
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.
干预措施: Cidofovir (Drug)
Cidofovir
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.
干预措施: Probenecid (Drug)
结局指标
主要结局
Systemic Absorption of Cidofovir
时间窗: 7 days
Systemic absorption of drug evaluated during and after intravesical administration. Blood collected for each sample in the following schedule: 1. T0 (pre-instillation) 2. 1 hour (after instillation) 3. 2 hours (after instillation-at the time of de-clamping) 4. 4 hours +/- 1 hour (after instillation) 5. 14 hours +/- 1 hour (14 hours after instillation or 12 hours from de-clamping). 6. 24 hours +/- 1 hour after instillation to ensure complete characterization of cidofovir elimination.
次要结局
未报告次要终点