EUCTR2010-018584-41-NL进行中（未招募）不适用
A phase II study of ARA290 as therapeutic strategy in no-option critical limb ischemia patients.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- MC
- 入组人数
- 8
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Critical limb ischemia
- •No option for conventional revascularization
- •Written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Overt diabetic disease
- •Clinically relevant abnormal history of physical and mental health other than conditions related to chronic kidney disease of patient, 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 chronic kidney disease of patient (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
- •Inability to follow the protocol and to comply with the follow up requirements
- •Any other condition that in the opinion of the investigator would complicate or compromise the study, or the well being of the subject.
研究者
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