EUCTR2013-000228-33-GB进行中（未招募）1 期
Inhibition of complement activation (eculizumab®) in Guillain-Barré Syndrome study - ICA-GBS
HS Greater Glasgow & Clyde0 个研究点开始时间: 2013年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- •Patients aged =18 years diagnosed with GBS according to NINDS diagnostic criteria
- •Onset of weakness due to GBS is less than 2 weeks ago
- •Patients who are unable to walk unaided for >10 meters
- •(grade = 3 on GBS disability scale)
- •Patients who are being considered for or already on IVIg treatment
- •First dose of eculizumab must be started within 2 weeks from onset of weakness and any
- •time during the IVIg treatment period
- •Signed informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Age<18 years
- •Patients who are being considered for, or already on, plasma exchange
- •Pregnancy or lactation
- •Patient shows clear clinical evidence of a polyneuropathy caused by e.g. diabetes mellitus
- •(except mild sensory), alcoholism, severe vitamin deficiency, and porphyria
- •Patient received immunosuppressive treatment (e.g. azathioprine, cyclosporine, mycofenolatemofetil,
- •tacrolimus, sirolimus or > 20 mg prednisolone daily) during the last month
- •Patient known to have a severe concurrent disease, like malignancy, severe cardiovascular disease, AIDS,
- •severe COPD, TB
- •Inability to comply with study related procedures or appointments during 6 months
- •Any condition that in the opinion of the investigator could increase the patient’s risk by participating in the
- •study or confound the outcome of the study
- •Related to the administration of eculizumab:
- •?Unresolved Neisseria meningitidis infection or history of meningococcal infection
- •?Unsuitable for antibiotic prophylaxis (e.g. due to allergy)
- •?Known hypersensitivity to eculizumab, murine proteins or to any of the excipients
- •?Known or suspected hereditary complement deficiencies
- •?Women of child-bearing potential who are unwilling to use effective contraception during treatment and for 5
- •months after treatment is completed.
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