NCT00038922终止1 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating, Safety and Exploratory Pharmacogenomic Study of Orally Administered Recombinant Human Interleukin Eleven (rhIL-11) in Patients With Mild to Moderate Left-Sided Ulcerative Colitis
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点开始时间: 2002年6月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
研究概览
简要总结
To explore the safety of orally delivered rhIL-11 in patients with mild to moderate left-sided ulcerative colitis.
To explore the effects of orally administered rhIL-11 on pharmacogenomics in blood samples and in colonic biopsy tissue samples.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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
- •Documented, signed informed consent to participate in this study
- •Age greater than or equal to 18 years
- •Documented diagnosis of ulcerative colitis by standard clinical criteria, including endoscopy (either flexible sigmoidoscopy or colonoscopy, sufficient to define the proximal limit of disease) with biopsy
排除标准
- •Crohn's disease
- •Ulcerative proctitis
- •Ulcerative colitis extending beyond the splenic flexure
研究者
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