NCT00073047已完成2 期
A Phase II, Randomized, Double-blind, Placebo-controlled, Multi-center, Dose-ranging Study of Intravenous Daclizumab in Patients With Moderate-to-severe Ulcerative Colitis
Facet Biotech69 个研究点 分布在 3 个国家目标入组 150 人开始时间: 2003年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 69
研究概览
简要总结
The purpose of The PROSPECT Study is to evaluate an investigational medication for the treatment of moderate to severe ulcerative colitis. This study is being conducted at up to 38 clinical research centers in the US, Canada, and Belgium, and is open to male and female patients 12 years and older. Participants in the study will have a number of visits to a research center over a five-month period. All study related care and medication is provided to qualified participants at no cost: this includes all visits, examinations, and laboratory work.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate to severe active ulcerative colitis diagnosed for at least 4 months.
- •Mayo score of 5-10 (inclusive)
- •Not used any investigational therapy for 30 days prior to screening
- •No treatment with monoclonal antibody therapy within 12 weeks of screening
- •No prior treatment with daclizumab
排除标准
- 未提供
研究者
研究点 (69)
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