EUCTR2008-007549-29-DK进行中（未招募）1 期
Trichuris suis Ova Therapy for Relapsing Multiple Sclerosis - a safety study - TRIMS A
Danish Multiple Sclerosis Research Center0 个研究点目标入组 10 人开始时间: 2009年5月6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
- 10
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 between 19 and 55 years
- •?relapsing course of multiple sclerosis (relapsing-remitting or secondary progressive MS with relapses)
- •?duration of the disease of at least 1 year
- •?EDSS ? 5.5 (expanded disability scale – see Appendix B and C)
- •?no disease modifying therapy or unchanged immunomodulatory therapy for the last 3 months
- •?at least 2 documented relapses during the last 24 months with the last relapse within the last 6 months or at least 1 documented relapse during the last 24 months with at least one Gadolinium positive lesion on a screening MRI.
- •?nine or more focal brain lesions on MRI according to the Barkhof criteria
- •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
- •?pregnancy or period of breastfeeding or missing adequate contraceptive protection for female premenopausal patients
- •?relapse in the last month prior enrolment
- •?treatment with steroids in the last 30 days
- •?previous treatment with mitoxantrone, cyclophosphamide or other intensive immunosupression, total irradiation or any kind of experimental therapy
- •?treatment with glatiramer acetate, azathioprine, IVIG or any other immunosuppressive or immunomodulatory drug apart from interferon-beta in the 6 months prior to enrolment
- •?cardiac insufficiency (NYHA III/IV), cardiomyopathy, significant cardiac dysrhythmia requiring treatment, instable or advanced ischemic heart disease (CCS III or IV), malignant hypertension
- •?diabetes mellitus and other autoimmune diseases
- •?history of renal insufficiency
- •?stay in tropical areas during the last 3 months
- •?eosinophilia in the blood (> 0,45 billion/l)
- •?concurrent systemic infections such as hepatitis B virus, hepatitis C virus, HIV and other infections which the investigator might find relevant.
研究者
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