Acute exacerbations of chronic obstructive pulmonary disease (COPD) MedDRA version: 8.1 Level: LLT Classification code 10009033 Term: Chronic obstructive pulmonary disease
Conditions
Interventions
Product Name: ODSH
Product Code: 2-O, 3-O Desulfated Heparin, PGX-100
Pharmaceutical Form: Solution for injection
INN or Proposed INN: N/A
CAS Number: N/A
Current Sponsor code: ODSH
Other descriptive
Sponsors
ParinGenix, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
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 30% but =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Incidence of treatment failure;Main Objective: The primary outcome of the study is “treatment failure”, meaning either that the patient failed to improve in the hoped for manner (in which case the hospitalization might be prolonged beyond some reasonable expectation) or having improved to the point where he/she was discharged, a relapse requiring some discrete medical treatment or health care utilization event occurred before the end of 21 days.;Secondary Objective: • Changes of pulmonary function test measures • C-reactive protein (CRP); • Improvement of dyspnea using the Borg CR10 Scale®; • Exercise capacity measured by the 6-minute walk test; • Change in the BODE • The need for intubation and mechanical ventilation 24 hours or later after starting study drug; • The amount of rescue beta-agonist use during Days 1, 2 and 3 • The oxygen requirements needed to maintain a pulse oximetry of 90-92% during Days 1-4 • Length of hospitalization and any ICU stay. • Time to new exacerbation if < 90 days from initiation of ODSH or placebo infusion • Incidence of exacerbations within 90 days of initiating ODSH or placebo infusion. • Incidence of re-hospitalization for COPD exacerbation within 60 days of initiating ODSH or placebo infusion. • Incidence of re-hospitalization for COPD exacerbation within 90 days of initiating ODSH or placebo infusion. • Subject deaths within 30 days, 60 days, and 90 days of initiation of ODSH infusion. | — |
Countries
Belgium, Germany
Outcome results
None listed