NL-OMON30808已完成3 期
A double-blind, randomised, placebo-controlled multicenter study to asses the safety and efficacy of AST-120 in mild to moderately active Crohn's patients with fistulas. - Study to asses the safety and efficacy of AST-120
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 9
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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 fistula 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
排除标准
- •Patients previously treated with infliximab for fistulas caused by Crohn*s disease and who did not respond to infliximab therapyInfliximab therapy within 3 months prior to enrollment in the studyPresence of symptomatic strictures or suggestion of significant clinical obstructionPatients with setons; unless setons are removed within 48 hours prior to study entryPresence 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§ Diagnosis of a psychiatric disorder within the past 2 years and not on a stable dose of medication for at least 6 months § 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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