NCT00206713终止3 期
Phase 3 Randomized, Double-Blind, Placebo-Controlled Multicenter Retreatment Study of Sargramostim (Leukine®) in Patients With Active Crohn's Disease and Prior Treatment Response to Sargramostim
Genzyme, a Sanofi Company0 个研究点目标入组 264 人开始时间: 2004年7月最近更新:
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
- 入组人数
- 264
- 主要终点
- Proportion of patients achieving clinical response or remission
研究概览
简要总结
The purpose of this study is to evaluate whether treatment with Leukine in patients with Crohn's disease who have previously responded to Leukine can be helped again, once they have relapsed.
详细描述
On 29 May 2009, Bayer began transitioning the sponsorship of this trial to Genzyme. NOTE: This study was originally posted by sponsor Berlex, Inc. Berlex, Inc. was renamed to Bayer HealthCare, Inc.
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 (Participant, Investigator)
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
- •You must be 18 years or older.
- •You must have active Crohn's disease at the time of screening.
- •You must be 18 years or older.
- •You must have active Crohn's disease at the time of screening.
- •You must be able to give yourself an injection of study drug or have another person who can help you give the injection.
- •You must not be pregnant and agree to use birth control if you are a sexually active male or female of childbearing potential.
排除标准
- •You may not be pregnant or breastfeeding.
- •You may not have a colostomy or ileostomy.
- •You may not be taking prohibited medications.
- •You may not have had GI surgery or a bowel obstruction in the last 6 months.
- •You may not have ever taken this drug or drugs of similar type in the past.
研究组 & 干预措施
Arm 1
Experimental
干预措施: Sargramostim (Leukine) (Drug)
Arm 2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of patients achieving clinical response or remission
时间窗: At Day 57 of the randomized retreatment phase
次要结局
- Proportion of patients achieving clinical response or remission(At the end of Week 8 of the open-label phase.)
研究者
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