Trial record 4 of 449 for:    "ulcerative colitis"

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
  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

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
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: NCT00355901

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

Additional Information:
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 July 22, 2014