NCT01706159终止2 期
A Multicenter, Randomised, Double-blind, Placebo-controlled, Multiple-dose Trial With rFXIII Administered to Subjects With Mild to Moderate Active Ulcerative Colitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 20
- 主要终点
- Endoscopic Remission Defined as a Modified Baron Score of 0
研究概览
简要总结
This trial is conducted in Europe. The aim of the trial is to investigate the effect of recombinant factor XIII (rFXIII) administered to subjects with mild to moderate active ulcerative colitis (UC).
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of ulcerative colitis for at least 3 months from the time of initial diagnosis. The diagnosis must have been confirmed by historical endoscopy and histology. The severity of disease must have been confirmed by endoscopy at screening
- •Currently receiving oral aminosalicylates at approved doses of at least 2g/day for at least 6 weeks. Doses of oral aminosalicylates should be stable for at least two weeks prior to dosing (Visit 2)
排除标准
- •Diagnosis of UC limited to the rectum (ulcerative proctitis only, defined as less than 15 cm from the anal verge)
- •Requiring hospitalisation for current episode of severe UC
- •Use of biologic therapies for the treatment of UC within 12 weeks prior to dosing (Visit 2)
- •Treatment failures to anti-tumour necrosis factor-alfa (anti-TNF-a) agents (e.g. infliximab, adalimumab)
- •Use of immunosuppressant agents (e.g. azathioprine) within 4 weeks prior to dosing (Visit 2)
- •Use of corticosteroids (oral, intravenous (i.v.), intramuscular (i.m.), or rectal ) within 14 days prior to dosing (Visit 2)
- •Use of enemas (corticosteroid or aminosalicylate) within 14 days prior to screening (Visit 1)
- •Use of cyclosporine, tacrolimus, D-penicillamine, leflunomide, methotrexate, mycophenolate mofetil, or thalidomide within 4 weeks prior to dosing (Visit 2)
- •Currently receiving total parenteral nutrition
研究组 & 干预措施
rFXIII
Experimental
干预措施: catridecacog (Drug)
Placebo
Active Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Endoscopic Remission Defined as a Modified Baron Score of 0
时间窗: At week 8
The primary endpoint was the binary variable ("responder" vs. "non-responder") where "responders" were the subjects with endoscopic remission (endoscopic mucosal healing) at Week 8, defined as a modified Baron score of 0. Subjects with a modified Baron score ≥1 were designated as "non-responders".
次要结局
- Clearance (CL) of rFXIII(Samples were collected before and up to 72 hours after the first dose of rFXIII.)
- Number of Adverse Events (AEs)(Week 0 to 10)
- Maximum Concentration (Cmax) of rFXIII(Samples were collected before and up to 72 hours after the first dose of rFXIII.)
- Remission (Clinical and Endoscopic)(At Week 8)
研究者
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