EUCTR2009-013220-24-CZ进行中（未招募）1 期
Plasma Exchange and Glucocorticoid in the Treatment of Anti-neutrophil Cytoplasm Antibody Associated Vasculitis: an International Randomised Controlled Trial. - PEXIVAS
Cambridge University Hospitals NHS Trust0 个研究点目标入组 704 人开始时间: 2010年3月19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
- 704
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) New or previous diagnosis of ANCA associated vasculitis
- •2) Positive test, at any point in the subject´s disease course, by ELISA, for proteinase 3-ANCA or myeloperoxidase - ANCA
- •3) Has a severe manifestation of vasculitis as defined by either a) renal vasculitis resulting in an estimated glomerular filtration rate below 50 ml/min; or b) lung haemorrhage
- •4) Provision of informed consent by patient or a surrogate decision maker
- •Are the trial subjects under 18? yes
- •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
- •1) Presence of concomitant anti-glomerular basement membrane disease or another vasculitic disease
- •2) Requirement for dialysis for >21 days in the period immediately preceeding enrollment
- •3) Age <15 (In the Czech Republic age < 18)
- •4) Pregnancy
- •5) Inability or unwillingness to comply with birth control/abstinence
- •6) Treatment for vasculitis with cyclophosphamide and/or glucocorticoids for >14 days prior to randomisation or rituximab >28 days prior to randomisation
- •7) A comorbidity on condition that, in the opinion of the investigator, precludes the use of cyclophosphamide/rituximab, glucocorticoids, or plasma exchange or absolutely mandates the use of plasma exchange.
- •8) Plasma Exchange in 3 months prior to randomization.
研究者
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