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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:
ClinicalTrials.gov Identifier:
NCT00355901
First Posted: July 25, 2006
Last Update Posted: August 5, 2008
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.
Information provided by:
Facet Biotech
  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:


Further study details as provided by Facet Biotech:

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

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
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


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

Additional Information:
ClinicalTrials.gov Identifier: NCT00355901     History of Changes
Other Study ID Numbers: 291-420
First Submitted: July 21, 2006
First Posted: July 25, 2006
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