NCT00947674终止4 期
Prospective, Randomized, Double-Blind, Sham Treatment Controlled Multicenter Study to Evaluate Efficacy and Safety of Cellsorba™EX Used for Leukocytapheresis (LCAP) in Patients With Steroid-Free, Active Ulcerative Colitis
适应症
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 52
- 试验地点
- 10
- 主要终点
- Clinical response
研究概览
简要总结
This is a prospective, randomized, double-blind, sham treatment controlled multicenter study.
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
- •Patients diagnosed to have UC in the active stage based on clinical symptoms and findings from endoscopy
- •Patients with pancolitis type or left-sided colitis type lesion of 15 cm or longer observed endoscopically
- •Patients with Mayo score between 5 and 10
- •Patients with Mayo sub-score (findings from flexible sigmoidoscopy) of 2 or 3
- •Patients not having received any corticosteroids (referred to as steroids) (p.o., i.v., enema, suppository) within the past 6 weeks
排除标准
- •Patients with a difficulty in peripheral vascular access
- •Patients having received ACE inhibitor (at least 10 times of its half-life time for interval needed before initiating the treatment)
- •Patients with toxic megacolon
- •Patients with a malignant disease or its experience
- •Patients with a severe cardiovascular disease (grade III or IV by the Classification of heart functions of the New York Heart Association (NYHA))
- •Patients with a liver or kidney disease (AST(GOT) or ALT(GPT) or total bilirubin or creatinine level which is 2 or more times higher than the upper limit of normal (abbreviated as ULN, hereinafter)
- •Patients suspected to have or having HBV or HCV or HIV or pathogenic bacteria
- •Patients on anticoagulant therapy or with abnormality in the blood coagulation system (PT or PTT levels which are 1.5 or more times higher than ULN
- •Pregnant women or patients with possible pregnancy
- •Breast feeding women
- •Patients weighing 40 kg or less
- •Patients with hemoglobin level of less than 6.5 mmol/L (10.5 g/dL)
- •Patients with platelet count of less than 150 x 103/mm3, 150 x 109/L (15 x 104/mm3)
- •Patients with white blood cell count of less than 3.5 x 109/L (3,500/mm3)
- •Patients with hypotension (with systolic blood pressure of 80 mmHg or less)
结局指标
主要结局
Clinical response
时间窗: at 8th week
次要结局
- Remission, Mayo scores, Mucosal healing, CRP(at 8th and 16th week)
研究者
研究点 (10)
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