NCT02108301Unknown4 期
Hepatitis C in Renal Transplant Recipients - Safety and Efficacy of a Conversion of Immunosuppression to High-dose Cyclosporine A and Its Impact on Hepatitis C Virus-replication, Parameters of Liver Function and Glucose Tolerance. An Open Label Trial.
Prof. Dr. Alice Schmidt1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2011年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- change in Hepatitis C-virus load at 12 weeks
研究概览
简要总结
The aim of the present trial is to evaluate whether the conversion of immunosuppression from tacrolimus to cyclosporine A induces changes in (i) hepatitis C-virus load, (ii) parameters of hepatic function and (iii) parameters of glucose tolerance in hepatitis C-positive renal transplant recipients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •written informed consent
- •prior renal transplantation
- •current tacrolimus-based immunosuppressive regimen
- •hepatitis C-infection
- •age 18-70 years
排除标准
- •current hemodialysis or peritoneal dialysis
- •pregnancy or breastfeeding
- •known contraindication for cyclosporine A-treatment
研究组 & 干预措施
tacrolimus-cyclosporine A
Experimental
conversion of immunosuppression from tacrolimus to cyclosporine A in hepatitis C-positive renal transplant recipients
干预措施: tacrolimus-cyclosporine A (Drug)
结局指标
主要结局
change in Hepatitis C-virus load at 12 weeks
时间窗: one day before and 4, 8 and 12 weeks after the conversion
次要结局
- change in oral glucose insulin sensitivity (OGIS) index at 12 weeks(one day before and 12 weeks after the conversion)
- change in serum hepcidin levels at 12 weeks(one day before and 12 weeks after the conversion)
研究者
Prof. Dr. Alice Schmidt
MD
Medical University of Vienna
研究点 (1)
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