EUCTR2009-013220-24-DK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 randomized 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3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) 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? 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) 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
相似试验
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 randomized controlled trial - PEXIVASEUCTR2009-013220-24-SECambridge University Hospitals NHS Trust500
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 randomized controlled trialAnti-neutrophil Cytoplasm Antibody (ANCA) Associated Vasculitis (which comprises Wegener's Granulomatosisand Microscopic Polyangiits)MedDRA version: 18.0Level: PTClassification code 10050894Term: Anti-neutrophil cytoplasmic antibody positive vasculitisSystem Organ Class: 10021428 - Immune system disordersEUCTR2009-013220-24-PLniwersytet Jagiellonski – Collegium Medicum700
进行中（未招募）
1 期
Plasma exchange and glucocorticoid dosing in the treatment of ANCA-associated vasculitis: a multicentre randomized controlled tria - PEXIVASEUCTR2009-013220-24-ITAZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIA704
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)ANCA associated vasculitisEUCTR2009-013220-24-GBAddenbrooke's Hospital704
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.ANCA associated vasculitisMedDRA version: 18.1Level: PTClassification code 10050894Term: Anti-neutrophil cytoplasmic antibody positive vasculitisSystem Organ Class: 10021428 - Immune system disordersEUCTR2009-013220-24-CZCambridge University Hospitals NHS Trust704