NCT01006941已完成2 期
Trichuris Suis Ova Therapy for Relapsing Multiple Sclerosis - a Safety Study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- MRI activity judged by the number of new or enlarging T2 lesions, number of Gd enhancing lesions and volume of T2 lesions
研究概览
简要总结
The hypothesis of this study is that treatment with Trichuris suis ova will be safe and effective as an oral treatment of patients with relapsing multiple sclerosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
- •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 12 months
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 mitoxantroneduring the last year
- •previous treatment with cyclophosphamide or other intensive immunosuppression, total irradiation
- •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
结局指标
主要结局
MRI activity judged by the number of new or enlarging T2 lesions, number of Gd enhancing lesions and volume of T2 lesions
时间窗: every 3. week. 3 MRI before treatment and 4 MRI during and after treatment
次要结局
未报告次要终点
研究者
Ana Voldsgaard
MD
Rigshospitalet, Denmark
研究点 (2)
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