Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-28 @ 10:31 PM
Study NCT ID:
NCT00102193
Status:
COMPLETED
Last Update Posted:
2008-09-08
First Post:
2005-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study for the Treatment of Ulcerative Colitis With Adacolumn
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 168}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-07'}, 'statusVerifiedDate': '2008-04', 'completionDateStruct': {'date': '2006-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-09-05', 'studyFirstSubmitDate': '2005-01-24', 'studyFirstSubmitQcDate': '2005-01-24', 'lastUpdatePostDateStruct': {'date': '2008-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-01-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effectiveness will be primarily evaluated at Week 12 by disease activity index (DAI) score'}, {'measure': 'Safety will be evaluated by determining the frequency and severity of adverse events'}]}, 'conditionsModule': {'keywords': ['Ulcerative Colitis, Apheresis'], 'conditions': ['Ulcerative Colitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate the safety and effectiveness of the Adacolumn Apheresis System to treat the signs and symptoms of ulcerative colitis.', 'detailedDescription': 'Trial Features:\n\n* Non-drug therapy\n* Most patients can remain on current treatment regimen, including prednisone, budesonide and medications such as Asacol (mesalamine), Pentasa (mesalamine), Colazal (balsalazide disodium) and Dipentum (olsalazine sodium) throughout the study\n\nComponents of the Study:\n\n* Study length is 24 weeks, which includes a screening visit, ten treatment visits over nine weeks and 4 follow-up appointments\n* Physical exams, laboratory tests and disease assessments conducted at no charge to the patient\n* 2:1 Randomization (treatment:sham)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Moderate to severe active ulcerative colitis with colonic involvement with ulcerative colitis beyond 15 cm of the anal verge\n* Adequate peripheral venous access to allow for completion of the apheresis treatments\n* Receiving one or more of the following medical therapies:\n\n \\*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\n* Agree to participate in the required follow-up visits\n* Able to complete a diary\n* Signed written informed consent document and authorization for use of protected health information\n\nKey Exclusion Criteria:\n\n* Evidence of toxic megacolon\n* Major surgery within the past 6 weeks or anticipated need for surgery within 12 weeks\n* Proctocolectomy, total colectomy, ileostomy, stoma or ileal pouch-anal anastomosis\n* Requiring in-patient hospitalization\n* A history of allergic reaction to heparin or heparin-induced thrombocytopenia\n* A history of hypersensitivity reaction associated with an apheresis procedure or intolerance of apheresis procedures\n* A history of severe cardiovascular or peripheral arterial diseases\n* A history of cerebral vascular diseases\n* Liver diseases\n* Renal insufficiency\n* Insulin-dependent Type I or Type II diabetes\n* Known bleeding disorder or use of concomitant anticoagulant therapy for purposes other than apheresis treatment\n* Any hypercoagulable disorder\n* Known infection with Hepatitis B or C, or HIV\n* Severe anemia\n* Leukopenia or granulocytopenia\n* Evidence of current systemic infection\n* Malignancy\n* Pregnant, lactating or planning to become pregnant during the course of the investigational study\n* Used within the last 30 days, an investigational drug, biologic or device or 5 half-lives, if known, for any investigational drug or biologic'}, 'identificationModule': {'nctId': 'NCT00102193', 'briefTitle': 'Study for the Treatment of Ulcerative Colitis With Adacolumn', 'organization': {'class': 'INDUSTRY', 'fullName': 'Otsuka America Pharmaceutical'}, 'officialTitle': 'A Randomized, Prospective, Double-Blinded, Placebo-Controlled (Sham-Controlled) Study to Evaluate the Safety and Effectiveness of the Adacolumn Apheresis System for the Treatment of Moderate to Severe Ulcerative Colitis', 'orgStudyIdInfo': {'id': '512-04-205'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Adacolumn Apheresis System', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic Scottsdale', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '91505', 'city': 'Burbank', 'state': 'California', 'country': 'United States', 'facility': 'Providence Clinical Research', 'geoPoint': {'lat': 34.18084, 'lon': -118.30897}}, {'zip': '94143-1623', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80033', 'city': 'Wheat Ridge', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rocky Mountain Gastroenterology Associates, PC', 'geoPoint': {'lat': 39.7661, 'lon': -105.07721}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta Gastroenterology Associates', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60637-1436', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago, Department of Medicine, Section of Gastroenterology', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky Medical Center', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '20815', 'city': 'Chevy Chase', 'state': 'Maryland', 'country': 'United States', 'facility': 'Metropolitan Gastroenterology Group', 'geoPoint': {'lat': 39.00287, 'lon': -77.07115}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital, GI Unit', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02135', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Tufts University School of Medicine, Caritas St. Elizabeth's Medical Center", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48047', 'city': 'Clinton Township', 'state': 'Michigan', 'country': 'United States', 'facility': 'Clinical Research Institute of Michigan', 'geoPoint': {'lat': 42.58698, 'lon': -82.91992}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth-Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '11021', 'city': 'Great Neck', 'state': 'New York', 'country': 'United States', 'facility': 'Long Island Clinical Research Associates', 'geoPoint': {'lat': 40.80066, 'lon': -73.72846}}, {'zip': '27599-7080', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina, Division of Digestive Disease & Nutrition', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Consultants for Clinical Research', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Digestive Disease Specialists Inc.', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '37232-2285', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75390-9016', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77555-0632', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Medical Branch', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}, {'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53792-5124', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin-Madison', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': 'T6G 2C8', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Walter Mackenzie Health Sciences Centre', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'V2S 3N5', 'city': 'Abbotsford', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Gastroenterology and Hepatology Clinic', 'geoPoint': {'lat': 49.05798, 'lon': -122.25257}}, {'zip': 'V6Z 1Y6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "St Paul's Hospital, University of British Columbia", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'K7L 5G2', 'city': 'Kingston', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hotel-Dieu Hospital', 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}, {'zip': 'N6A 4G5', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Health Sciences Centre, South Street Campus', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'N6A 5A5', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Health Sciences Centre, University Campus', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'K1Y 4E9', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Ottawa Hospital-Civic Campus', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M5B 1W8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Michael's Hospital", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5G 1X5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Mount Sinai Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'G6V 3W6', 'city': 'Lévis', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hôtel-Dieu de Lévis', 'geoPoint': {'lat': 46.80326, 'lon': -71.17793}}, {'zip': 'H3T 1E2', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Sir Mortimer B. Davis Jewish General Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Yosuke Komatsu, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Otsuka America Pharmaceutical'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Otsuka America Pharmaceutical', 'class': 'INDUSTRY'}}}}