NCT00322270已完成3 期
Phase 3, Multicenter, Multinational, Open-Label Study to Evaluate the Safety and Efficacy of Alfimeprase in Subjects With Occluded Central Venous Access Devices (SONOMA-3)
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 试验地点
- 36
- 主要终点
- Safety and efficacy
研究概览
简要总结
To evaluate the safety profile of alfimeprase as assessed by monitoring of adverse events, serious adverse events and major bleeding events for up to 120 minutes following the instillation of study drug to an occluded central venous access device.
详细描述
Further study details as provided by Nuvelo
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Must give written informed consent
- •Ages 18 or older
- •Unable to withdraw at least 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 or pheresis
- •Previous treatment with plasminogen activator for current episode of catheter occlusion
- •Less than 18 years of age
- •Any evidence of mechanical or nonthrombotic occlusion
- •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
Safety and efficacy
时间窗: up to120 minutes post study drug dosing
次要结局
- Adverse events, serious adverse events and bleeding events(24 hours post dosing)
- Adverse events up to day 30 visit(day 28-45) after instillation of study drug(approximately 28-45 days post dosing)
研究者
研究点 (36)
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