NCT01279577已完成2 期
Double-blind, Randomised, Placebo-controlled, Multi-centre Phase II Study to Evaluate the Efficacy and Safety of Three Different Dosages of Oral Trichuris Suis Ova (TSO) Suspension in Active Crohn's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 254
- 试验地点
- 1
- 主要终点
- Rate of clinical remission at week 12 (LOCF) defined as a CDAI< 150
研究概览
简要总结
This study will run in centers in Germany, Denmark, Austria, Czech Republic, and Switzerland, only.
This proof-of-concept study aims to evaluate the efficacy of three doses of oral TSO suspension vs. placebo for the induction of remission in Crohn's disease.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent,
- •Man or woman between 18 and 75 years of age,
- •Established diagnosis of Crohn's disease (CD) since at least 3 months prior to screening confirmed by endoscopic and histological, or endoscopic and radiological criteria,
- •Negative pregnancy test in females of childbearing potential.
排除标准
- •Bowel surgery within the last 3 months prior to baseline,
- •Resection of more than 50 cm of the ileum,
- •Ileostomy or colostomy,
- •Septic complications,
- •Evidence of infectious diarrhoea (i.e., pathogenic bacteria or Clostridium difficile toxin in stool culture),
- •Abscess, perforation, fistulas, or perianal lesions,
- •Immediate surgery required (e.g., major stenosis, serious bleeding, peritonitis, ileus),
- •Clinical signs of stricturing disease,
- •Parenteral or tube feeding,
- •Abnormal hepatic function (ALT or ALP > 2.5 x upper limit of normal [ULN] at screening), liver cirrhosis, or portal hypertension,
- •Abnormal renal function (Cystatin C > ULN) at screening,
- •Any severe concomitant cardiovascular, renal, endocrine, or psychiatric disorder, which in the opinion of the investigator might have an influence on the patient's compliance or the interpretation of the results,
- •Any condition associated with significant immunosuppression,
- •Active malignancy or treatment with anticancer drugs during the last 5 years.
- •Existing or intended pregnancy or breast-feeding,
- •Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial.
研究组 & 干预措施
Low dose TSO
Experimental
Low dose suspension of TSO
干预措施: Low dose TSO (Drug)
Medium dose TSO
Experimental
Medium dose suspension of TSO
干预措施: Medium dose TSO (Drug)
High dose TSO
Experimental
High dose suspension of TSO
干预措施: High dose TSO (Drug)
Placebo
Placebo Comparator
Placebo solution
干预措施: Placebo (Drug)
结局指标
主要结局
Rate of clinical remission at week 12 (LOCF) defined as a CDAI< 150
时间窗: 12 weeks
次要结局
- Reduction of > 100 points in CDAI(12 weeks)
- Adverse events(12 weeks)
研究者
研究点 (1)
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