NCT00926575终止3 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Safety and Efficacy of orBec® (Oral Beclomethasone 17,21-Dipropionate)in Conjunction With Ten Days of High-Dose Prednisone Therapy in the Treatment of Patients With Gastrointestinal GVHD
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Soligenix
- 入组人数
- 140
- 主要终点
- The Proportion of Subjects With GVHD Treatment Failure
研究概览
简要总结
Use of an oral topically-active glucocorticoid with limited side effects will control the gastrointestinal inflammatory process of GVHD and minimize glucocorticoid exposure.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Receipt of allogeneic hematopoietic cell transplant
- •Diagnosis of GI graft vs. host disease (GVHD)
- •No GI infection
- •Must be able to swallow tablets
- •Must be able to read and understand informed consent
- •Adequate birth control methods for the duration of the study
排除标准
- •Significant Skin GVHD
- •Liver GVHD
- •Persistent vomiting
- •HIV positive
- •Pregnancy/lactation
研究组 & 干预措施
orBec®
Experimental
Investigational drug
干预措施: oral beclomethasone 17,21-dipropionate (Drug)
Placebo
Placebo Comparator
Control
干预措施: Placebo (Drug)
结局指标
主要结局
The Proportion of Subjects With GVHD Treatment Failure
时间窗: Day 80
The primary endpoint is the occurrence (yes, no) during the 80-day study period of GVHD treatment failure defined as use of prednisone or equivalent IV corticosteroids at doses higher than stated in the protocol, or use of any additional other glucocorticoid (including unblinded BDP) or addition of other immunosuppressant medications, in response to uncontrolled signs or symptoms of GVHD
次要结局
- Cumulative Exposure to Prednisone(Day 80)
- Survival Status(Day 200)
研究者
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