NCT00409461终止不适用
Comparison of Sirolimus Alone With Sirolimus Plus Tacrolimus in Type 1 Diabetic Recipients of Cultured Islet Cell Grafts
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 试验地点
- 2
研究概览
简要总结
Proof of concept study in islet transplantation, two treatment arms (ATG SIR-TAC versus ATG SIR) each consisting of ten type 1 diabetic patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 接受健康志愿者
- 否
入选标准
- •Type 1 insulin-dependent diabetic patients
- •C-peptide < 0.15 nmol/l (<0.45 µg/l) 6 min. after glucagon IV (1mg) (glycemia > 180 mg/dl)
- •diabetic nephropathy
- •hypoglycaemic unawareness
排除标准
- •smoker before transplantation
- •plasma creatinine > 2 mg/dl
- •albuminuria >1000 mg/24 hrs
- •abnormal liver function
- •history of thrombosis or pulmonary embolism
- •history of malignancy, tuberculosis or chronic viral hepatitis
- •history of any other serious illness which could be relevant for the protocol
- •HLA antibodies
- •EBV antibody negative
- •HIV 1 & 2 antibody positive
研究者
研究点 (2)
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