NCT00563108Unknown不适用
A Double-blind Randomized Single-center Trial of Basiliximab for the Treatment of Acute Graft-versus-host Disease After Allogeneic Stem Cell Transplantation.
Hospital Authority, Hong Kong1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2004年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Resolution of GVHD by Day 12
研究概览
简要总结
Graft-versus-host disease (GVHD) contributes substantially to transplant-related morbidity and mortality. Steroids remains first line therapy for acute GVHD but there is currently no consensus on second line therapy for those in whom steroids have been ineffective. Basiliximab has been shown to be a safe and effective immunosuppresant in the prevention and treatment of rejection after renal transplantation and its role in acute GVHD prophylaxis and treatment has been described favourably. This is a randomized control trial to investigate its efficacy and safety in the management of acute GVHD post allogeneic stem cell transplantation (SCT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Grade II to IV acute GVHD after SCT
排除标准
- •Known allergy to basilixmab
结局指标
主要结局
Resolution of GVHD by Day 12
时间窗: 12 days
次要结局
- Duration and grading of acute GVHD(100 days)
- Total dose of steroid and immunosuppresant(100 days)
- Mortality, GVHD-related and all cause(100 days)
研究者
研究点 (1)
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