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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

This study has been terminated.
Sponsor:
Information provided by:
Facet Biotech
ClinicalTrials.gov Identifier:
NCT00355901
First received: July 21, 2006
Last updated: August 2, 2008
Last verified: August 2008
History of Changes
  Purpose

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 Intervention Phase
Ulcerative Colitis
 Drug: Visilizumab (Nuvion®; HuM291)
 Phase 2

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Facet Biotech:

Estimated Enrollment: 300
Study Start Date: September 2006
Estimated Study Completion Date: November 2012
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00355901

  Show 40 Study Locations
Sponsors and Collaborators
PDL BioPharma, Inc.
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00355901     History of Changes
Other Study ID Numbers: 291-420
Study First Received: July 21, 2006
Last Updated: August 2, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Facet Biotech:
Ulcerative Colitis
Colitis
Steroid-Refractory
Visilizumab
Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC)

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

ClinicalTrials.gov processed this record on May 16, 2013