NCT00630656已完成2 期
A Phase 2 Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Talactoferrin Alfa in Patients With Severe Sepsis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Agennix
- 入组人数
- 190
- 试验地点
- 34
- 主要终点
- All-cause mortality
研究概览
简要总结
Study will evaluate the safety and potential benefit of recombinant human talactoferrin as an addition to the standard care of severe sepsis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Age greater than or equal to 18 years
- •Onset of severe sepsis within the previous 24 hours
- •Must be receiving antibiotic therapy
- •Informed consent form signed by patient, legal next-of-kin or legal guardian
- •Able to take medication by mouth or feeding tube
排除标准
- •Receipt of investigational medication within 4 weeks prior to participation in the study
- •Pregnant or breast-feeding
- •Severe congestive heart failure
- •Known severe HIV infection
- •Presence of severe burns
- •Patients on high dose immunosuppressants
- •Patients whose death is considered imminent
- •Patients whose life expectancy for concurrent illness is less than 6 months
- •Severe hypoxic encephalopathy or persistent vegetative state
- •Severe liver disease
- •Patient, legal representative or patient's primary physician not committed to providing full, aggressive life support
研究组 & 干预措施
1
Experimental
Talactoferrin alfa
干预措施: Talactoferrin alfa (Drug)
2
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
All-cause mortality
时间窗: 28-day
次要结局
- All-cause mortality(6 months)
研究者
研究点 (34)
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