EUCTR2009-013220-24-GB进行中（未招募）1 期
Plasma Exchange and Glucocorticoid Dosing in the Treatment of Anti-neutrophil Cytoplasm Antibody Associated Vasculitis: an International Randomised Controlled Trial - PEXIVAS (Version 1)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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
入选标准
- •1) New or previous diagnosis of ANCA associated vasculitis
- •2) Has either PR3 or MPO positive antibody(ANCA) binding by ELISA or equivalent
- •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:
- •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) 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 years
- •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 that, in the opinion of the investigator, mandates the use plasma exchange or precludes the use of reduced dose glucocorticoids
研究者
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