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An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory 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.
 
ClinicalTrials.gov Identifier: NCT00355901
Recruitment Status : Terminated
First Posted : July 25, 2006
Last Update Posted : August 5, 2008
Sponsor:
Information provided by:
Facet Biotech

Brief Summary:
To assess the effects of visilizumab on the safety of subsequent salvage therapies in subjects who experienced disease progression in a previous visilizumab study and subsequently received salvage therapy.

Condition or disease Intervention/treatment
Ulcerative Colitis Drug: Visilizumab (Nuvion®; HuM291)

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Study Type : Observational
Estimated Enrollment : 300 participants
Time Perspective: Prospective
Official Title: An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis
Study Start Date : September 2006
Study Completion Date : November 2012

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Previous participation in a visilizumab study of IVSR-UC.
  • Disease progression while enrolled in a previous visilizumab study, and subsequent treatment with salvage therapy.

Exclusion Criteria:

  • Unable to understand the purpose and risks of the study, or unwilling or unable to provide a signed and dated informed consent.
  • For U.S. sites, unwilling or unable to provide authorization to use protected health information.

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 ClinicalTrials.gov identifier (NCT number): NCT00355901


Locations
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United States, California
San Francisco, California, United States, 94115
United States, Florida
Gainesville, Florida, United States, 32610
United States, Georgia
Atlanta, Georgia, United States, 30342
United States, Kentucky
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Worcester, Massachusetts, United States, 01655
United States, Minnesota
Rochester, Minnesota, United States, 55905
United States, Missouri
St. Louis, Missouri, United States, 63110
United States, New York
Manhasset, New York, United States, 11030
Mineola, New York, United States, 11501
New York, New York, United States, 10021
New York, New York, United States, 10029
United States, Ohio
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Hershey, Pennsylvania, United States, 17033
United States, South Carolina
Charleston, South Carolina, United States, 29425
United States, Utah
Salt Lake City, Utah, United States, 84107
Australia, South Australia
Bedford Park, South Australia, Australia
Australia, Victoria
Box Hill, Victoria, Australia
Australia
Fremantle, Australia, 6160
Liverpool, Australia, 2170
Austria
Wien, Austria, A-1090
Belgium
Ghent, Belgium, B-9000
Leuven, Belgium, 3000
Roeselare, Belgium, 8800
Canada, Manitoba
Winnipeg, Manitoba, Canada, R3A-139
Canada, Ontario
Hamilton, Ontario, Canada, L8N 3Z5
Czech Republic
Brno, Czech Republic
Praha, Czech Republic
France
Amiens Cedex, France, 80054
Lille, France, 59037
Paris, France, 75010
Germany
Freiburg, Germany, D-79106
Hungary
Béri Balogh Adám, Hungary, H-7100
Vac, Hungary, H-2601
Vásvari Pál, Hungary, H-9024
Ireland
Dublin, Ireland
Italy
Bologna, Italy, 40138
Netherlands
Amsterdam, Netherlands, 1105 AZ
Norway
Oslo, Norway
Tromso, Norway
Ukraine
Kharkov, Ukraine, 61001
Sponsors and Collaborators
PDL BioPharma, Inc.
Additional Information:
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ClinicalTrials.gov Identifier: NCT00355901    
Other Study ID Numbers: 291-420
First Posted: July 25, 2006    Key Record Dates
Last Update Posted: August 5, 2008
Last Verified: August 2008
Keywords provided by Facet Biotech:
Ulcerative Colitis
Colitis
Steroid-Refractory
Visilizumab
Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC)
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Visilizumab
Immunologic Factors
Physiological Effects of Drugs