EUCTR2008-000938-49-DE进行中（未招募）不适用
Placebo-controlled Randomized Trial to evaluate the Effect of Elafin on Cytokine Profiles after Major Surgery - Phase II - Elafin
Proteo Biotech AG0 个研究点开始时间: 2009年1月27日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •1.Subject has carcinoma of the esophagus that will be treated with esophagectomy
- •2.Subject is informed and given ample time and opportunity to think about his participation and has given his written informed consent.
- •3.Subject is willing and able to comply with all trial requirements.
- •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
- •1.Less than 18 years of age
- •2.Child-bearing potential
- •3.Participation in another trial with an investigational product within the last 4 weeks
- •4.White blood cell count < 4,000 cells/mm³
- •5.White blood cell count > 12,000 cells/mm³
- •6.Greater than 10% immature neutrophils
- •7.Body temperature > 38°C
- •8.Body temperature < 36°C
- •9.Pulse rate > 90 bpm at eligibility
- •10.Serum creatinine > 2.0 mg/dL
- •11.Severe chronic liver disease
- •12.Severe central nervous system or severe psychiatric disease
- •13.Impaired spontaneous ventilation
- •14.Acute myocardial infarction within the last 6 weeks
- •15.Known heart failure, NYHA Classification III or IV
- •16.Active infection requiring systemic administration of antibiotics
- •17.Previous bone marrow transplant
- •18.Previous organ transplant (heart, kidney, liver)
- •19.Current immunosuppressive therapy such as cortisone, cyclosporine or azothioprine
- •20.Cancer-related chemotherapy within the last 2 weeks
研究者
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