NCT00186667已完成2 期
An Open Label Study of Sirolimus as Primary Therapy for the Treatment of Chronic GVHD Following Allogeneic Bone Marrow Transplant
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Evaluate the efficacy of clinical activity of sirolimus in combination with cyclosporine and corticosteroids as first line therapy for the treatment of chronic Graft Versus Host Disease.
研究概览
简要总结
Evaluate the clinical activity of sirolimus in combination with cyclosporine and corticosteroids as first line therapy for the treatment of chronic Graft Versus Host Disease.
详细描述
An Open Label Study of Sirolimus as Primary Therapy for the Treatment of Chronic GVHD Following Allogeneic Bone Marrow Transplant
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
- •active chronic GvHD
- •ANC > 1000/mm^3
- •therapeutic cyclosporine
排除标准
- •uncontrolled systemic infection
- •elevated serum creatinine
结局指标
主要结局
Evaluate the efficacy of clinical activity of sirolimus in combination with cyclosporine and corticosteroids as first line therapy for the treatment of chronic Graft Versus Host Disease.
次要结局
- Evaluate the safety of clinical activity of sirolimus in combination with cyclosporine and corticosteroids as first line therapy for the treatment of chronic Graft Versus Host Disease.
研究者
研究点 (2)
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