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Research Study in Patients With Severe Ulcerative Colitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Facet Biotech
ClinicalTrials.gov Identifier:
NCT00032305
First received: March 14, 2002
Last updated: March 6, 2012
Last verified: March 2012
  Purpose

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 Intervention Phase
Ulcerative Colitis
Drug: Visilizumab
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Facet Biotech:

Estimated Enrollment: 20
Study Start Date: March 2002
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00032305

Locations
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
  More Information

No publications provided by Facet Biotech

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Facet Biotech
ClinicalTrials.gov Identifier: NCT00032305     History of Changes
Other Study ID Numbers: 291-406
Study First Received: March 14, 2002
Last Updated: March 6, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Facet Biotech:
Colitis
Gastrointestinal Disease
Digestive System Disease
Intestinal Disease
Colonic Disease

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Colonic Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 27, 2014