EUCTR2006-000197-69-CZ进行中（未招募）1 期
A pilot, open-label, multi-center clinical trial to investigate the safety and efficacy of Bovine-Calf Intestinal Alkaline Phosphatase in patients with moderate to severe ulcerative colitis
AM-Pharma B.V.0 个研究点目标入组 24 人开始时间: 2006年3月10日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
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
- •·age ³ 18 years, and
- •·capable of understanding the purpose and risks of the study and have provided a signed and dated written informed consent,
- •prior to the study baseline, been treated with oral steroid medication, of which > 2 weeks on oral prednisone equivalent of at least 40 mg/day, and still have: §active ulcerative colon disease documented by a MAYO-score of 6-11, and§active ulcerative colon disease documented by a MTWSI score of 7-15
- •·prior to the study baseline, documented clinical inability to decrease or stop the course of oral steroid medication. Patients have been treated for a minimum of 12 weeks, and still have:
- •§chronic active ulcerative colon disease documented by a MAYO-score of 6-11,
- •and§chronic active ulcerative colon disease documented by a MTWSI score of 7-15
- •·prior to the study baseline, been treated with a stable dosage of azathioprine for a minimum of 12 weeks, and have a moderate to severe relapse defined as:§chronic active ulcerative colon disease documented by a MAYO-score of 6-11, andchronic active ulcerative colon disease documented by a MTWSI score of 7-15
- •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
- •§ulcerative colitis, requiring immediate surgical, endoscopic, or radiological intervention;
- •·history of large bowel surgery
- •·history of serious infections
- •·positive stool cultures, including Clostridium Difficile
- •·significant organ dysfunction
- •·pregnancy, nursing mothers, or women of childbearing potential without appropriate use of contraceptives
- •·treatment with:
- •1.an altered dose of any 5-ASA preparation within 4 weeks of screening
- •2.an altered dose of azathioprine or mercaptopurine within 4 weeks of screening (stable dosage of immunosuppressives is allowed), or start of azathioprine in the last 3 months prior to baseline
- •3.probiotics, antibiotics, methotrexate or cyclosporine within 1 month resp. 2 months prior of screening
- •4.any experimental treatment for this population e.g. infliximab, tacrolimus, FK506 or other anti TNF-a therapy) within 2 months of screening
研究者
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