Phase 3, Multicenter, Multi-National, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Alfimeprase in Subjects With Occluded Central Venous Access Devices
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Catheter function restoration at fifteen minutes after initial instillation of study drug.
研究概览
简要总结
The purpose of the study is to compare the safety and effectiveness of alfimeprase to a placebo in restoring function of occluded central catheters.
详细描述
Primary Outcomes: The ability to withdraw at least 3 ml of blood and infuse more at least 5 mL of sterile saline through the occluded catheter lumen at 15 minutes after receiving initial instillation of study drug.
Secondary Outcomes:
The ability to withdraw at least 3 mL of blood and infuse at least 5 mL of sterile saline through the occluded catheter lumen at 30 minutes following a single instillation of study drug and at 30 minutes following a second instillation of study drug if patency is not restored within 30 minutes of the first instillation.
Safety:
- Adverse events
- Major bleeding events
- Change in laboratory values.
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
- Double
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
- •Must give written informed consent
- •Unable to withdraw 3 mL of blood from a central venous access device
- •Hemodynamically stable
- •Available for follow-up assessments
排除标准
- •Inability to infuse at least 2 mL of saline through the catheter
- •Catheter placed less than 48 hours prior to detection of occlusion
- •Catheter used for hemodialysis of pheresis
- •Less than 18 years of age
- •Evidence of mechanical or nonthrombotic occlusion
- •Receipt of any thrombolytic agent within 24 hours of randomization
- •In the opinion of the investigator, subject is at "high risk" for bleeding events of embolic complications, or has a condition for which bleeding constitutes a significant hazard
- •Increased risk for drug extravasation
- •Pregnant, lactating, or actively menstruating women and women of child-bearing potential who are not using adequate contraceptive precautions (e.g. intrauterine device, oral contraceptives, barrier methods, or other contraception deemed adequate by the investigator)
- •Known right-to-left cardiac shunt, patent foramen ovale, or atrial/ventricular septal defect
- •Participation in any other study of an investigational device, medication, biologic, or other agent within 30 days before enrollment and until the 30-day follow up visit
- •Any other subject feature that in the opinion of the investigator should preclude study participation
结局指标
主要结局
Catheter function restoration at fifteen minutes after initial instillation of study drug.
时间窗: 15 minutes
次要结局
- Catheter function restoration at 30 minutes after initial instillation of study drug.(30 minutes)
- Catheter function restoration at 30 minutes after second dose instillation of study drug if patency was not restored after first dose.(additional 30 minutes)