Study for the Treatment of Ulcerative Colitis With Adacolumn
Ulcerative Colitis
About this trial
This is an interventional treatment trial for Ulcerative Colitis focused on measuring Ulcerative Colitis, Apheresis
Eligibility Criteria
Key Inclusion Criteria: Moderate to severe active ulcerative colitis with colonic involvement with ulcerative colitis beyond 15 cm of the anal verge Adequate peripheral venous access to allow for completion of the apheresis treatments Receiving one or more of the following medical therapies: *sulfasalazine, *mesalamine and other 5-ASA agents, *prednisone or 6-mercaptopurine or azathioprine OR Have not received the above medical therapies due to intolerance or demonstrated non-response Agree to participate in the required follow-up visits Able to complete a diary Signed written informed consent document and authorization for use of protected health information Key Exclusion Criteria: Evidence of toxic megacolon Major surgery within the past 6 weeks or anticipated need for surgery within 12 weeks Proctocolectomy, total colectomy, ileostomy, stoma or ileal pouch-anal anastomosis Requiring in-patient hospitalization A history of allergic reaction to heparin or heparin-induced thrombocytopenia A history of hypersensitivity reaction associated with an apheresis procedure or intolerance of apheresis procedures A history of severe cardiovascular or peripheral arterial diseases A history of cerebral vascular diseases Liver diseases Renal insufficiency Insulin-dependent Type I or Type II diabetes Known bleeding disorder or use of concomitant anticoagulant therapy for purposes other than apheresis treatment Any hypercoagulable disorder Known infection with Hepatitis B or C, or HIV Severe anemia Leukopenia or granulocytopenia Evidence of current systemic infection Malignancy Pregnant, lactating or planning to become pregnant during the course of the investigational study Used within the last 30 days, an investigational drug, biologic or device or 5 half-lives, if known, for any investigational drug or biologic
Sites / Locations
- Mayo Clinic Scottsdale
- Providence Clinical Research
- University of California, San Francisco
- Rocky Mountain Gastroenterology Associates, PC
- Atlanta Gastroenterology Associates
- University of Chicago, Department of Medicine, Section of Gastroenterology
- University of Kentucky Medical Center
- Johns Hopkins Hospital
- Metropolitan Gastroenterology Group
- Massachusetts General Hospital, GI Unit
- Tufts University School of Medicine, Caritas St. Elizabeth's Medical Center
- University of Michigan
- Clinical Research Institute of Michigan
- Mayo Clinic
- Dartmouth-Hitchcock Medical Center
- Long Island Clinical Research Associates
- University of North Carolina, Division of Digestive Disease & Nutrition
- Duke University Medical Center
- Consultants for Clinical Research
- Cleveland Clinic Foundation
- Digestive Disease Specialists Inc.
- Vanderbilt University Medical Center
- University of Texas Southern Medical Center
- University of Texas Medical Branch
- University of Washington Medical Center
- University of Wisconsin-Madison
- Walter Mackenzie Health Sciences Centre
- Gastroenterology and Hepatology Clinic
- St Paul's Hospital, University of British Columbia
- Hotel-Dieu Hospital
- London Health Sciences Centre, South Street Campus
- London Health Sciences Centre, University Campus
- The Ottawa Hospital-Civic Campus
- St. Michael's Hospital
- Mount Sinai Hospital
- Hôtel-Dieu de Lévis
- Sir Mortimer B. Davis Jewish General Hospital