EUCTR2005-005363-28-BE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 65 years of age
- •Body Weight: (=40 kg)
- •Documented diagnosis of Crohn’s disease, including patients with documentted diagnosis of ileitis, colitis, or ileocolitis
- •Presence of at least one draining fistula. Women with rectovaginal fistulas are included if they have = 1 other externally draining 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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients previously treated with infliximab for fistulas cuased by Chrohn's disease and who did not experience 100% fistula closure in response to infliximab therapy.
- •Receiving infliximab therapy within 12 months prior to enrollment in the study
- •Presence of symptomatic strictures or suggestion of significant obstruction
- •Patients with setons; 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
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