EUCTR2005-002048-25-SE进行中（未招募）不适用
A pilot study to investigate the use of recombinant cholera toxin B subunit in the treatment of active Crohn’s disease.
SBL Vaccin AB0 个研究点目标入组 25 人开始时间: 2005年6月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 25
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
- •Male or female aged 18 to 70 years.
- •A previously established diagnosis of Crohn´s disease verified with
- •enteroclysis/small bowel follow-through, barium enema, endoscopy or
- •histology. Should be performed within 24 months prior to study initiation.
- •Active disease of mild to moderate degree. CDAI (Crohn´s Disease Activity
- •Index) score = 220 and = 400.
- •If ongoing treatment with sulphasalazine (SASP) or 5-ASA, corticostereoids
- •or immunomodulators, the dose regimen must have been unchanged for
- •at least 4 weeks and must have been initiated at least 12 weeks prior to
- •Give written informed consent to participate.
- •Willing and able to communicate with the Investigator and understand the
- •requirements of the study.
- •Females should unless being menopausal agree to use reliable
- •contraception (hormonal contraceptives or intra-uterine device), at least
- •from 1 month prior to inclusion until three months after last intake of study
- •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
- •Treatment with metronidazole within the last four weeks.
- •Treatment with any biological drug, including infliximab, within 12 weeks.
- •Has received Dukoral in the last year.
- •Patient with a known intestinal stricture or symptoms or history indicating
- •a stenotic condition.
- •Active fistulating disease.
- •Any condition which would limit the patient’s ability to complete the study
- •in the opinion of the Investigator.
- •History of drug or chemical abuse in the year before the study.
- •Receipt of any other investigational product in the month before study
- •Concomitant participation in any other clinical study.
- •Donation of blood 6 weeks before study entry or at any time during the
- •Females who are pregnant or lactating.
研究者
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