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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 304

Inclusion Criteria

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

Exclusion Criteria

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;

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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