EUCTR2005-005363-28-AT进行中（未招募）不适用
A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULAS
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •18 to 70 years of age
- •Body Weight: (=40 kg)
- •Documented diagnosis of Crohn’s disease, including patients with documented diagnosis of ileitis, colitis, or ileocolitis
- •Presence of at least one draining perianal fistula. Patients with enterocutaneous fistulas can be included if they have = 1 draining perianal fistula. Women with rectovaginal fistulas are included if they have = 1 draining perianal fistula.
- •Crohn’s Disease Activity Index (CDAI) score < 400
- •Platelet count (thrombocytes) =100,000/µL
- •Able and willing to comply with all protocol procedures
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients previously treated with infliximab for fistulas cuased by Crohn's disease and who did not respond to infliximab therapy.
- •Infliximab therapy within 3 months prior to enrollment in the study
- •Presence of symptomatic strictures or suggestion of significant clinical obstruction
- •Patients with setons are excluded unless setons are removed at least 48 hours prior to study entry
- •Presence of entero-entero, recto-vesicular, entero-vesicular fistulas
- •The patient is unable to stay on a stable dose of concomitant Crohn’s disease medication(s) for at least 10 weeks in the opinion of the investigator
- •Currently symptomatic untreated diarrhea due to conditions other than mild to moderately active Crohn’s disease (e.g. bacterial or parasitic gastroenteritis, bile salt diarrhea, etc.)
- •Severe diarrhea defined by > 10 liquid bowel movements per day
- •Other local manifestations of mild to moderately active Crohn’s disease such as abscesses, or other disease manifestations for which surgery might be indicated, or which might preclude utilization of a CDAI to assess response to therapy (e.g. short bowel syndrome)
- •Receiving Total Parenteral Nutrition (TPN) as the sole source of nutrition within 3 weeks of Screen
- •Hemoglobin < 8.5 g/dL (females) or hemoglobin < 10 g/dL (males) at Screen
- •Women who are pregnant, breast feeding, or planning to become pregnant during the study
- •Other major physical or major psychiatric illness within the last 6 months that in the opinion of the investigator would affect the patient's ability to complete the trial
- •Uncontrolled systemic disease
- •Patients undergoing chemotherapy for the treatment of cancer
研究者
相似试验
进行中（未招募）
不适用
A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULASEUCTR2005-005363-28-CZOcera Therapeutics, Inc.240
进行中（未招募）
不适用
A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN PATIENTS WITH NON-CONSTIPATING IRRITABLE BOWEL SYNDROMEEUCTR2007-001950-18-BEOcera Therapeutics, Inc.100
进行中（未招募）
不适用
A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULASEUCTR2005-005363-28-DEOcera Therapeutics, Inc.240
进行中（未招募）
不适用
A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULASThe two main categories of inflammatory bowel disease (IBD) are ulcerative colitis and Crohn’s disease. Crohn’s disease is characterized by recurring episodes of suppurative inflammation of any part of the bowel, from the mouth to the anus. This can result in strictures, microperforations, and fistulas. Crohn’s patients typically expetience fever, weight loss, stomatitis, perianal fistulae and/or fissures, arthritis, and erythema nodosum.EUCTR2005-005363-28-BEOcera Therapeutics, Inc.240
进行中（未招募）
不适用
A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULASThe two main categories of inflammatory bowel disease (IBD) are ulcerative colitis and Crohn’s disease. Crohn’s disease is characterized by recurring episodes of suppurative inflammation of any part of the bowel, from the mouth to the anus. This can result in strictures, microperforations, and fistulas. Crohn’s patients typically expetience fever, weight loss, stomatitis, perianal fistulae and/or fissures, arthritis, and erythema nodosum.EUCTR2005-005363-28-HUOcera Therapeutics, Inc.240