Phase II, Open-label, Randomized, Multiple Ascending Dose Confirmation of the Safety and Tolerability of Brincidofovir in Subjects With BK Virus Infection (Viremia) After Kidney Transplantation (BASTION)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 主要终点
- Incidence of treatment-emergent adverse events (TEAEs)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Male or female, at least 18 years of age at the time of signing the informed consent at screening.
- •Kidney transplant recipient.
- •"BK viral load increase and >= 3.6 log IU/mL" at 2 weeks post immunosuppression reduction or "BK viral load does not decrease by >= 0.3 log IU/mL" at 4 weeks post immunosuppression reduction during prescreening.
- •(Note: Immunosuppressant reduction needs to be continued during the screening period).
- •eGFR >= 30 mL/min.
- •Subjects under immunosuppression with tacrolimus, MMF/Myfortic, and/or corticosteroid.
排除标准
- •Subjects who weigh >= 120 kg.
- •National Institutes of Health/NCI CTCAE Grade 2 or higher diarrhea (ie, increase of >= 4 stools per day over usual pretransplant stool output) within 7 days before Day
- •Poor clinical prognosis, including active malignancy or use of vasopressors other than low dose (eg, =< 5 ug/kg/min) dopamine for renal perfusion within 7 days before Day
- •Use of renal replacement therapy within 7 days before Day
- •History of intolerance to cidofovir or related compounds (ie, other nucleotide derivatives [adefovir or tenofovir]).
结局指标
主要结局
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of treatment-emergent adverse events (TEAEs), particularly those of the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 severity and serious adverse events
Incidence of treatment-related TEAEs
Incidence of treatment-related TEAEs
Incidence of adverse events (AEs) requiring permanent discontinuation of BCV
Incidence of adverse events (AEs) requiring permanent discontinuation of BCV
Absolute and changes over time in safety laboratory parameters
Absolute and changes over time in safety laboratory parameters (ie, hematology, blood chemistry, and urinalysis)
Change from baseline in BK viral load in plasma
时间窗: through follow-up
Change from baseline in BK viral load in plasma measured through follow-up for each subject
Change from baseline in BK viral load in urine
时间窗: through follow-up
Change from baseline in BK viral load in urine measured through follow-up for each subject
Peak BK viral load in plasma
时间窗: from Week 2 Day 1 through follow-up
Peak BK viral load in plasma from Week 2 Day 1 through follow-up for each subject
Time-averaged area under the viremia-time curve for BK viral load in plasma
时间窗: from baseline through follow-up
Time-averaged area under the viremia-time curve for BK viral load in plasma from baseline through follow-up for each subject
次要结局
未报告次要终点