EUCTR2017-001117-86-GB进行中（未招募）1 期
A phase IV, prospective, randomised single-blind UK multicentre non-inferiority trial of low-dose versus standard dose rituximab for prevention of relapses in acquired TTP - Elective rituximab in TTP
niversity College London0 个研究点目标入组 52 人开始时间: 2018年5月18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
- 52
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. Male or female, age>18
- •2.Antibody-mediated TTP with at least one previous acute TTP episode
- •3.ADAMTS13 activity dropping to =15% documented on 2 separate occasions on different days, , with platelets>150 and no evidence of microangiopathic haemolytic anaemia and LDH <1.5 x upper limit normal
- •4.Females of childbearing potential and males agree to use an effective method of contraception from the time consent is signed for 12 months after treatment completion. Effective methods of contraception acceptable for this trial are oral, implanted or injected hormonal methods of contraception, IUD or IUS, and barrier methods of contraception
- •5.Females of childbearing potential have a negative pregnancy test within 7 days prior to being randomised. Participants are considered not of child bearing potential if they are surgically sterile (i.e. they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal
- •6.Willing and able to provide written informed consent.
- •7. Willing and able to comply with the trial protocol
- •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 55
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 7
排除标准
- •1. Females who are pregnant, planning pregnancy or breastfeeding
- •2. Concurrent and/or recent involvement in other research that is likely to interfere with the intervention within 3 months of study enrolment
- •3. Known allergies to rituximab
- •4. Patients currently undergoing plasma infusion/exchange
- •5. Patients on therapy with other immunosuppressive medication (except steroids)
- •6. Patients with a current acute severe infection or a history of recurring or chronic infections or underlying conditions which may further predispose patient to serious infection.
研究者
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