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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

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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)

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


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Sponsors and Collaborators
PDL BioPharma, Inc.

Additional Information:
ClinicalTrials.gov Identifier: NCT00355901     History of Changes
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:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases