Evaluation of Safety and Thrombolytic Effect of Ascending Doses of DS-9231 (TS23) in Subjects With Intermediate-risk (Sub-massive) Acute Pulmonary Embolism (PE)
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Percent change from baseline in total thrombus volume
研究概览
简要总结
The primary objective of this study is to evaluate safety and initial effectiveness of DS-9231 when taken together with current standard of care. Evaluation will be done with low, medium and then high doses of DS-9231 versus placebo, in participants with medium-risk acute pulmonary embolism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Had protocol-defined pulmonary embolism (PE)
- •Has stable systolic blood pressure (SBP) >90 mm Hg
- •Has evidence of right ventricular (RV) dysfunction
- •Has executed informed consent
排除标准
- •Has history or plans for thrombotic therapy outside protocol allowance
- •Has other contraindications for participation
- •Has laboratory results outside protocol-specified limits
- •Is pregnant, nursing, and/or not willing or able to use protocol-defined contraceptives
- •Has history or condition, or participated in another investigational study that (per protocol or in the opinion of the investigator) might compromise:
- •the safety or well-being of the participant or the participant's offspring
- •the safety of study staff
- •the analysis of results
研究组 & 干预措施
DS-9231
In conjunction with standard of care, participants will receive an intravenous infusion delivering DS-9231 at ascending dose levels in Cohort 1, 2, and 3
干预措施: DS-9231 (Drug)
Placebo
In conjunction with standard of care, participants will receive an intravenous infusion delivering only saline solution as matching placebo comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Percent change from baseline in total thrombus volume
时间窗: Baseline, 48-96 hours after study drug administration
Percentage of participants with various gradations of decrease in total thrombus volume
时间窗: Baseline, 48-96 hours after study drug administration
Number of participants with major or clinically relevant nonmajor bleeding
时间窗: within 7 days after study drug administration
Number of participants with adverse events
时间窗: within 30 days after study drug administration
次要结局
- Percentage of participants with with various gradations of decrease in total thrombus volume(30 days after study drug administration)
- Percent change from baseline in total thrombus volume(Baseline, 30 days after study drug administration)
- Percent change from baseline in RV/ left ventricle (LV) diameter ratio(Baseline, 48-96 hours and 30 days after study drug administration)
- Number of participants with PE-related deaths(within 30 days after study drug administration)
- Number of participants who died from any cause(within 30 days after study drug administration)
- Percentage of participants with clinical deterioration requiring additional rescue therapy for PE(within 30 days after study drug administration)
- Number of participants with non-bleeding adverse events (AEs)(within 30 days after study drug administration)
- Number of participants with anti-drug antibodies (ADAs)(within 30 days after study drug administration)
- Plasma concentration of DS-9231(Baseline to 30 days after study drug administration)
- Number of participants with with recurrent, objectively documented venous thromboembolism (VTE)(within 30 days after study drug administration)
- Participant-reported quality of life on a proprietary scale(Baseline, Day 30 after study drug administration)
- Number of participants re-hospitalized for any reason(within 30 days after study drug administration)
- Number of participants with major or clinically relevant nonmajor bleeding(within 30 days after study drug administration)