CESA 5.10 Investigation to Compare the Efficacy and Safety of the Adacolumn® Apheresis Device in Patients With Active Ulcerative Colitis

Exclusion Criteria

• •1. Febrile (\> 38ºC)
• •2. Evidence of toxic megacolon
• •3. Anticipated need for surgery within 12 weeks
• •4. Known obstructive diseases of the gastrointestinal system
• •5. Proctocolectomy, total colectomy, ileostomy, stoma or ileal pouch-anal anastomosis
• •6. A history of allergic reaction to heparin or heparin-induced thrombocytopenia
• •7. A history of hypersensitivity reaction associated with an apheresis procedure or intolerance of apheresis procedures
• •8. Requires a central venous access catheter for the apheresis treatments
• •9. Known infection with enteric pathogens, pathogenic ova or parasites, or a positive assay for C. difficile toxin
• •10. Hypotension (systolic blood pressure \< 90 mmHg and/or diastolic blood pressure \< 65 mmHg) at screening visit only
• •11. Uncontrolled hypertension (systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 120 mmHg) despite medical therapy at screening visit only
• •12. A history of myocardial infarction or unstable angina within the past 6 months
• •13. A history of coronary artery bypass grafting surgery or angioplasty within the past 6 months
• •14. A history of physical findings compatible with a cerebrovascular accident
• •15. Congestive heart failure (New York Heart Association Class III or IV)
• •16. Prosthetic heart valve, pacemaker or other permanent implant
• •17. Severe cardiovascular or peripheral vascular disease
• •18. Liver disease defined as levels of SGOT \[AST\], SGPT \[ALT\] or alkaline phosphatase \> 2.5x the upper limit of the normal range for the laboratory performing test
• •19. History of cirrhosis
• •20. Renal insufficiency, defined as serum creatinine \> 150% of the upper limit of the normal range for the laboratory performing the test
• •21. Insulin-dependent type I or type II diabetes. (Patients receiving oral antidiabetic treatment can be included.)
• •22. Known bleeding disorder (PT or PTT \> 1.5x the upper limit of the normal range for the laboratory performing the test), or concomitant anticoagulant therapy for purposes other than apheresis treatment
• •23. Prior history suggestive of a hypercoagulable disorder, including 1 or more episodes of pulmonary embolism or deep vein thrombosis
• •24. Known infection with hepatitis B or C, or HIV
• •25. Abnormal hematology parameters defined as severe anemia with hemoglobin \< 8.5 g/dL, white blood cell count of \< 3,500/ul and a granulocyte count \< 2,000/μl
• •26. Fibrinogen level \> 700 mg/dL
• •27. Major surgery within the past 6 weeks
• •28. Infection:
• •* Active infections less than 4 weeks from successful completion of antibiotic treatment for routine bacterial infection
• •* Febrile viral infection within 4 weeks of entry into the clinical investigation
• •* Less than 12 weeks from conclusion of therapy for systemic fungal infections
• •29. Malignancy within the past 2 years other than surgically cured skin carcinoma or cervical dysplasia (CIN I-II)
• •30. History of dysplasia or carcinoma of the colon
• •31. Current drug or alcohol abuse
• •32. Pregnant, lactating or planning to become pregnant during the course of the clinical investigation
• •33. Used within the last 30 days, an investigational drug, biologic or device or 5 half lives, if known, for any investigational drug or biologic
• •34. Received cyclosporine or tacrolimus within the last 4 weeks
• •35. Received infliximab within the last 8 weeks
• •36. Received oral budesonide within the last 2 weeks
• •37. Used topical therapy for ulcerative colitis within the last 2 weeks
• •38. Previously received Adacolumn® treatments