KCT0007693尚未招募未知
A Study to Evaluate the Safety and Efficacy of ATORM-C in the Patients with Intestinal Behcet’s Disease
Koera University Guro Hospital0 个研究点目标入组 10 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1) 19 years of age or older
- •2) Patients with severe Behcet's enteritis who have been treated with anti-TNFa for more than 1 year
- •3)A patient with an intestinal ulcer with a long axis greater than 10 mm and measurable by colonoscopy
- •4) Patients whose intestinal ulcer size measured at the time of examination is reduced or enlarged by less than 50% compared to that measured at the previous visit.
- •5) Patients who understand the purpose of this clinical trial, voluntarily decides to participate in this clinical trial, and agrees in writing to comply with restrictions
排除标准
- •Patients who fall under any of the following are not eligible to participate in this clinical study.
- •1) Suspected type and indeterminate colitis
- •2) Patients with autoimmune diseases other than Behcet's disease
- •3) Patients with serious complications requiring surgical intervention such as severe stricture, perforation, large abscess, and massive gastrointestinal bleeding.
- •4) Patients with malignant tumors including colorectal cancer
- •5) Patient who underwent bowel resection within the last 6 months or intra-abdominal surgery within 3 months
- •6) Patients with a history of infectious diseases within one month of screening
- •7) Patients for whom bowel preparation for colonoscopy is contraindicated
- •8) Patients with hypersensitivity to bovine protein or fibrin glue
- •9) Pregnant or lactating women
- •10) As male subjects who are women of childbearing age and sexual partners of women of childbearing potential, ? very effective contraceptive methods (hormonal contraception, intrauterine device (IUD (Intrauterine device), IUS (Intrauterine system) , vasectomy, tubal ligation, etc.); or not promising the use of a double barrier (male condoms, female condoms, cervical caps, diaphragms or contraceptive sponges) when highly effective methods of contraception are not available; or ? If you do not promise not to donate sperm until the end of the clinical trial
- •11) Patients with a history of participating in clinical trials within the last 30 days
- •12) Patients with inability to communicate that could interfere with safety and other assessments
研究者
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