NCT00643071已完成3 期
Tacrolimus (FK506) P-III, Open-label Study in Severe Refractory Ulcerative Colitis Patients or Patients Who Attended and Received Placebo in F506-CL-1107 Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 32
- 主要终点
- Improvement of Disease Activity Index score (DAI score)
研究概览
简要总结
Patients with severe refractory ulcerative colitis (UC) or those who received placebo in study F506-CL-1107 will receive tacrolimus for a maximum of 12 weeks. Safety and efficacy will be evaluated.
详细描述
Patients with severe refractory ulcerative colitis (UC) or those who received placebo in study F506-CL-1107 study can participate in this study. Patients will receive tacrolimus for a maximum of 12 weeks in an open-label study manner. Improvement of Disease Activity Index (DAI) score and other efficacy scores will be evaluated during the drug administration period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 64 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe refractory UC patients who meets the following criteria
- •Disease activity: more than 6 times of stool a day, bloody stool, moderate to severe endoscopic finding
- •Steroid resistant or dependent
- •Moderate to severe refractory UC patients who participated and received placebo in F506-CL-1107 study
排除标准
- •Mild or fulminant type
- •Renal failure patients, hepatic failure patients
- •Patients taking 6-mercaptopurine, cyclosporin or other immunosuppressants within 12 weeks prior to entry
- •Patients who received LCAP or GCAP within 2 weeks prior to entry
- •Patients who changed the dose of steroid or started steroid within 2 weeks prior to entry
- •Patients who changed the dose of steroid or started steroid within 1 week prior to entry in case they received more than 40 mg/ day or 1mg/kg/day of steroid just before the study
研究组 & 干预措施
1
Experimental
干预措施: Tacrolimus (Drug)
结局指标
主要结局
Improvement of Disease Activity Index score (DAI score)
时间窗: 12 weeks
次要结局
- Changes of DAI score ( Total & each item)(2 weeks)
- Changes of clinical severity and symptom(12 weeks)
- Endoscopic finding(12 weeks)
- Patients impression(12 weeks)
- Amount of steroid(12 weeks)
研究者
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