EUCTR2011-003687-78-IT进行中（未招募）不适用
anreotide Autogel for the treatment of patients with Idiopathic Pulmonary Fibrosis (IPF) - IPF/LANREOTIDE/2011-01
AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI0 个研究点开始时间: 2012年3月5日最近更新:
适应症
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
- •1. Diagnosis of Idiopathic Pulmonary Fibrosis (IPF) 2. Age > 30, <75 3. Life expenctancy of more than 1 year 4. DLCO%>40% 5. expression of somatostatin receptors assessed by 68Ga-DOTA-NOC PET/CT 6. Adeguate bone marrow function, normal hepatic and kidney function, assessed by tests performed within the 14 days before starting treatment: leukocytes>3.000/µl, neutrophils (ANC) >1.500/µl, paltelets>100.000/µl, bilirubin <1.5 times the normal upper (ULN), AST(SGOT) and ALT(SGPT) <2.5xULN, creatinin <1.25xULN (or >1.25xULN and <1.5xULN con creatinin clearance>60ml/min). 7. Signed Informed Consent
- •Are the trial subjects under 18? no
- •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 5
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1. Pregnancy 2. Breast feeding 3. Healthy volunteers 4. Age <30, >75 years 5. Other forms of Interstitial lung disorders 6. Patients in emergency state 7. Individuals with reduced approval competence expressing any reluctance to participate to the study as well as those not understanding the purpose of the study 8. Severe cardiovascular conditions: stroke (?6 mesi), AMI (?6 mesi), astable angina, heart congestive failure NYHAII or higher, serious arythmias requiring treatment 9. Concomitant inflammatory disorders 10. Severe Parkinson disease 11. Colelithiasis 12. Informed consent not signed 13. Concomitant or recent neoplastic
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