NL-OMON34878撤回2 期
A phase II study of ARA 290 as therapeutic strategy in no-option critical limb ischemia patients. - ARA 290 as therapeutic strategy in critical limb ischemia patients.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Critical limb ischemia
- •No option for conventional revascularization
- •Written informed consent
- •Expected life expectancy > 1 year
排除标准
- •Overt diabetic disease
- •Clinically relevant abnormal history of physical and mental health other than conditions related to CLI, as determined by medical history taking (as judged by the investigator);
- •Clinically relevant abnormal laboratory results, ECG, vital signs, or physical findings other than conditions related to CLI (as judged by the investigator)
- •Subject has a history of severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
- •Participation in an investigational drug trial in the 3 months prior to administration of the initial dose of study drug or more than 4 times per year
- •Use of erythropoietin, systemic corticosteroids (e.g. prednisone etc.) and other immune modulatory drugs
研究者
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