EUCTR2006-006378-32-DE进行中（未招募）不适用
An Open-Label Phase Followed by a Randomized, Double-Blind, Placebo-Controlled Phase in a Study Designed to Evaluate Intravenous 2-O, 3-O Desulfated Heparin (ODSH) in Hospitalized Subjects with Exacerbations of Chronic Obstructive Pulmonary Disease
ParinGenix, Inc0 个研究点目标入组 304 人开始时间: 2007年2月21日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 304
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. Male and female patients requiring hospitalization for treatment of an exacerbation of COPD;
- •2. Established diagnosis of COPD based upon medical history;
- •3. Age of 40 years or more;
- •4. History of 20 pack years of cigarette smoking;
- •5. Anticipated need for four or more days of hospitalization, in the investigator’s judgment;
- •6. Normal prothrombin time (PT = 15 seconds or = the upper limit of normal value for the study site or corresponding INR);
- •7. Normal activated partial thromboplastin time (aPTT = 38 seconds or = the upper limit of normal value for the study site);
- •8. Platelet count > 80,000 per mm3, hemoglobin > 9.5 g/dL but < 18 g/dL, and hematocrit > 30% but < 60% at screening;
- •9. Able and willing to provide informed consent and to comply with the study procedures.
- •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. Participation in another clinical trial of a therapeutic drug during past 30 days;
- •2. Subjects hospitalized for a COPD-related illness within 30 days prior to study entry;
- •3. Primary diagnosis of asthma exacerbation;
- •4. COPD exacerbation caused primarily by clinical heart failure, pneumothorax, or pulmonary embolism;
- •5. Intubation and mechanical ventilation at the time of potential enrollment;
- •6. Lobar pneumonia. Subjects with patchy peri-bronchial infiltrates from bronchopneumonia are permitted;
- •7. Bronchiectasis, where it is the primary source of pulmonary dysfunction;
- •8. Abnormal renal function with estimated creatinine clearance < 30 mL/min;
- •9. Active gastrointestinal ulcer disease or gastrointestinal bleeding within the past 60 days;
- •10. Lung cancer that is not in clinical remission;
- •11. Clinical need for therapeutic anticoagulation with warfarin or other vitamin K antagonists;
- •12. Clinical need for anticoagulation treatment or DVT prophylaxis with heparin, LMWH, heparin derivatives and heparinoids;
- •13. Clinical need for therapy with clopidogrel (Plavix®);
- •14. Congenital or acquired hemostatic defect (use of aspirin or acetylsalicylic acid for cardiovascular prophylaxis not exceeding 325 mg/day is permitted)
- •15. AST or ALT greater than 1.5X the upper limit of normal;
- •16. Subjects with overt cor pulmonale, who suffer hepatic congestion
- •17. Current substance abuse, or alcohol-related organ dysfunction;
- •18. Clinical history of heparin-induced thrombocytopenia (HIT);
- •19. History of HIV, hepatitis B or hepatitis C;
- •20. Women of child-bearing potential;
- •21. Major surgery or stroke or myocardial infarction (MI) within the past 60 days from Screening. Recent minor surgery is permitted;
研究者
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