NCT00082121已完成2 期
Safety and Efficacy of TP10, a Complement Inhibitor, in Adult Women Undergoing Cardiopulmonary Bypass Surgery
Avant Immunotherapeutics18 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2004年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 18
- 主要终点
- Reduction in death & myocardial infarction (MI)
研究概览
简要总结
The purpose of this study is to determine if the study drug (TP10), which blocks complement release, can reduce such side effects of complement inflammation as chest pain or heart attacks and be taken safely in women who undergo cardiopulmonary bypass surgery.
详细描述
During cardiac surgery, a substance called "complement" is released by the body. This complement causes inflammation, which can lead to side effects such as chest pain, heart attacks, or heart failure. The purpose of this study is to determine if the study drug (TP10), which blocks complement release, can reduce such side events and be taken safely in women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •To undergo high-risk cardiac surgery with cardiopulmonary bypass pump (CPB)
- •CABG alone or with valve surgery
排除标准
- •Acute myocardial infarction (heart attack) within a 3 days of entering the study
- •Conditions that may interfere with interpretation of electrocardiogram data
- •History of immune deficiency syndrome
- •Planned supplemental cardiac surgery or other surgery
- •Pregnancy or lactation
结局指标
主要结局
Reduction in death & myocardial infarction (MI)
次要结局
未报告次要终点
研究者
研究点 (18)
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