A Phase II Randomized Study of Cidofovir Versus Best Supportive Care for Polyomavirus Hominis Type I (BK) Virus Related Hemorrhagic Cystitis After Stem Cell Transplant
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Number of Patients with Microbiologic Response
研究概览
简要总结
The goal of this clinical research study is to learn if adding cidofovir to the standard of care can improve symptoms of hemorrhagic cystitis caused by the BK virus as compared to standard of care alone. The safety of cidofovir will also be studied.
详细描述
The Study Drug:
Cidofovir is an anti-viral drug that is designed to treat or prevent infections caused by certain kinds of viruses.
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups and you will have an equal chance of being in either group:
- If you are in Group 1, you will receive standard of care drugs and cidofovir. The doctor will tell you more about the standard of care drugs that you will take and the risks for them.
- If you are in Group 2, you will only receive standard of care drugs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HSCT patients with symptomatic hemorrhagic cystitis (minimal Grade 1 symptoms of HC per NCI criteria) and positive BKV in urine >1x103 DNA copies/ml
- •Age >/= 6 years
- •Patient must sign the informed consent document.
排除标准
- •Creatine clearance < 55 ml/min, calculated using ideal body weight (IBW) using Cockcroft-Gault equation
- •Concomitant use of foscarnet, liposomal amphotericin B or aminoglycoside
- •Use of cidofovir for bladder instillation
- •Use of formalin or hyperbaric oxygen treatment
研究组 & 干预措施
Standard of Care + Cidofovir
Cidofovir 0.5 mg/kg IV 3 x week for 4 weeks
干预措施: Cidofovir (Drug)
No Cidofovir
Standard of Care: Pharmacologic management of pain, spasms, and urinary urgency with medications, hyper-hydration, or continuous bladder irrigation.
干预措施: No Cidofovir (Other)
结局指标
主要结局
Number of Patients with Microbiologic Response
时间窗: 8 weeks
Response defined as improvement in symptoms based on questionnaire, reduction or stability in grade of hemorrhagic cystitis, and level of virus must be a 1 log reduction from baseline when the BKV was first diagnosed.
次要结局
未报告次要终点