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Research Study in Patients With Severe Ulcerative Colitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00032305
Recruitment Status : Completed
First Posted : March 18, 2002
Last Update Posted : March 7, 2012
Information provided by (Responsible Party):
Facet Biotech

Brief Summary:
The purpose of the study is to evaluate an intravenous (by injection) investigational medication to treat severe ulcerative colitis refractory to steroid therapy. The research is being conducted at up to 8 clinical research sites in the US and is open to both men and women ages 18 to 70 years old. Participants in the study will have a number of visits to a research site. All study-related care and medication is provided to qualified participants at no cost: this includes all visits, examinations and laboratory work.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: Visilizumab Phase 2 Phase 3

Detailed Description:
A Phase I, dose-escalation, pilot study designed to obtain safety and tolerability data on visilizumab administered to patients with severe ulcerative colitis that has failed to respond to steroid therapy. Patients who are currently receiving IV corticosteroids, but whose disease has not responded after at least 5 days of this therapy, will be eligible for the study.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Dose-Escalation, Pilot Study of Visilizumab in Patients With Severe Ulcerative Colitis That is Refractory to Corticosteroids
Study Start Date : March 2002
Actual Primary Completion Date : November 2005
Actual Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  1. A diagnosis of ulcerative colitis verified by colonoscopy or barium enema performed within 36 months prior to study entry.
  2. Active disease despite ongoing treatment with steroids

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00032305

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United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States
University of California
San Francisco, California, United States, 94115
United States, Georgia
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States
United States, Illinois
The University of Chicago Medical Center
Chicago, Illinois, United States
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
Mount Sinai School of Medicine
New York, New York, United States
United States, Pennsylvania
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, United States
Sponsors and Collaborators
Facet Biotech

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Facet Biotech Identifier: NCT00032305    
Other Study ID Numbers: 291-406
First Posted: March 18, 2002    Key Record Dates
Last Update Posted: March 7, 2012
Last Verified: March 2012
Keywords provided by Facet Biotech:
Gastrointestinal Disease
Digestive System Disease
Intestinal Disease
Colonic Disease
Additional relevant MeSH terms:
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Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Immunologic Factors
Physiological Effects of Drugs