NCT00505648终止3 期
Treatment of DRESS (Drug Reaction With Eosinophilia and Systemic Symptoms) With Tegeline®
University Hospital, Rouen4 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2008年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 4
- 主要终点
- express healing of visceral attacks, healing of polyadenopathy and body temperature, biological abnormal values normalisation, express healing of cutaneous and mucous diseases immunological study of the T cell index phenotype
研究概览
简要总结
Efficacy and tolerance of Tegeline® treatment in hypersensitivity syndrome. Immunological study of the T cell index phenotype and functionality in hypersensitivity syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >= 18
- •Cutaneous and/or mucous eruption
- •Polyadenopathy
- •Body temperature > 38°C
- •Hematology disorders : Hypereosinophily > 1.5 G/l, lymphocytosis > 5G/l, atypical blood lymphocytes
- •Consent obtained from patient
排除标准
- •Age < 18
- •No consent obtained from patient
- •IgV allergy
- •Dress with very sérious visceral attack and vital diagnostic (sharp cardiac insufficiency, sharp respiratory insufficiency, hepatic insufficiency, sharp renal insufficiency)
- •Oral therapy or immunosuppressive therapy (Methotrexate, cyclosporine, cyclophosphamide, etc.)
- •IgA deficiency,
- •MCI >=35
- •Sharp renal insufficiency before Dress with creatinaemia < 60 ml/min (Cockroft)
结局指标
主要结局
express healing of visceral attacks, healing of polyadenopathy and body temperature, biological abnormal values normalisation, express healing of cutaneous and mucous diseases immunological study of the T cell index phenotype
时间窗: 1 year
次要结局
未报告次要终点
研究者
研究点 (4)
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