EUCTR2008-005871-92-SE进行中（未招募）1 期
En fas 1 studie av effekt av Tysabri (natalizumab), en IgG4 humaniserad monoklonal antikropp specifik mot VLA-4 (integrin alfa-4), administrerad som infusion 1 gång/månad under 3 månader hos patienter med kronisk idiopatisk trombocytopen purpura (ITP). - Tysabri for ITP
Sahlgrenska University Hospital0 个研究点目标入组 20 人开始时间: 2008年12月10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
- 入组人数
- 20
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
- •1) Chronic primary ITP since at least 6 months before screening and a platelet count below 50 x 109/l on day 1 or 24 hours before the first dose.
- •2) No immunosuppressive treatment at day 1 or 24 hours before the first dose.
- •3) Acceptable contraceptive usage.
- •4) At least 18 years of age.
- •5) Signed informed consent.
- •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
- •1) Ongoing immunosuppressive treatment.
- •2) Presence of malignancy.
- •3) Pregnancy or lactation.
- •4) Not willing to participate in the study.
- •5) Participation in other clinical trial.
- •6) Not willing to use contraception for 3 months.
- •7) Ongoing JC virus infection.
研究者
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