EUCTR2006-003957-25-IT进行中（未招募）不适用
Rare Diseases with microvascular involvement. High Dose Intravenous N-acetylcysteine versus Iloprost for early, rapidlyprogressive diffuse Systemic Sclerosis (Scleroderma) - N-Acetylcisteine vs Iloprost in SSc
AZIENDA OSPEDALIERO UNIVERSITARIA OSPEDALI RIUNITI UMBERTO I - G.M.LANCISI - G.SALESI0 个研究点开始时间: 2007年7月9日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •a. edSSc (ACR criteria);
- •b. age 18-80 years;
- •c. ability to give an informed consent;
- •d. use of an acceptable method of birth control (if women in childbearing age).
- •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
- •a. connective tissue diseases other than SSc;
- •b. history of intolerance to the study drugs;
- •c. severe cardiac failure (NYHA >=3 or left ventricular ejection fraction <40%), recent (<6 months) history of myocardial
- •infarction; symptomatic ischemic myocardial disease, ventricular tachyarrhythmia, atrial fibrillation;
- •d. resting PaO2 <60mm/hg or Carbon Monoxide Diffusing Capacity <40% of predicted
- •e. creatinina clearance below 90ml/h
- •f. ALT or bilirubin above two times upper normal limits;
- •g. bronchial asthma;
- •h. hemorrhagic diathesis
研究者
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