NCT00180089已完成3 期
Efficacy and Safety of Orale Budesonide in the Prevention of Acute Gastrointestinal Graft-versus-host Disease Following Allogenic Stem Cell Transplantation
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 242
- 试验地点
- 2
- 主要终点
- incidence of acute gastrointestinal (GI) GVHD in the active group versus placebo group
研究概览
简要总结
The purpose of this study is to determine whether orale budesonide is effective in the prevention of acute gastrointestinal graft-versus-host disease (GVHD) following allogenic stem cell transplantation.
详细描述
The purpose of this study is to determine whether orale budesonide is effective in the prevention of acute gastrointestinal graft-versus-host disease (GVHD) following allogenic stem cell transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •planned allogenic stem cell or bone marrow transplantation
- •HLA identity (max. 1 mismatch)
- •standard GVHD prophylaxis with cyclosporin A or tacrolimus combined with MTX, +/- ATG or Campath1H
- •written informed consent
排除标准
- •history of allogenic transplantation
- •in vitro T-cell depleted transplant
- •pretreatment with budesonide within the previous 4 weeks
- •known intolerance to budesonide
- •gastrointestinal infections
- •portal hypertension
- •concomitant infectious diseases
- •liver cirrhosis, impaired liver function
- •severe mental disorder
- •lack of compliance
- •drug or alcohol abuse
- •pregnancy, lactation
- •childbearing potential without effective contraception
结局指标
主要结局
incidence of acute gastrointestinal (GI) GVHD in the active group versus placebo group
次要结局
- incidence of infectious complications
- grade of acute GI GVHD
- safety
- overall and disease-free survival 1 yr after transplant
- incidence of chronic GI GVHD
研究者
研究点 (2)
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