ClinicalTrials.gov
ClinicalTrials.gov Menu

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Visilizumab in Subjects With 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: NCT00502294
Recruitment Status : Withdrawn
First Posted : July 17, 2007
Last Update Posted : June 25, 2009
Sponsor:
Collaborator:
PDL BioPharma, Inc.
Information provided by:
Facet Biotech

Brief Summary:
To compare the efficacy of visilizumab at 5 mcg/kg/day administered intravenously (IV) on Days 1 and 2 to placebo in subjects with IVSR-UC.

Condition or disease Intervention/treatment Phase
Intravenous Steroid-Refractory Ulcerative Colitis Drug: Visilizumab (HuM291; Nuvion®) Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis

Resource links provided by the National Library of Medicine






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, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females, 18 years of age or older.
  • Diagnosis of UC verified by endoscopy within 60 months prior to consent.

Additional Information:
ClinicalTrials.gov Identifier: NCT00502294     History of Changes
Other Study ID Numbers: 291-416
First Posted: July 17, 2007    Key Record Dates
Last Update Posted: June 25, 2009
Last Verified: July 2008

Keywords provided by Facet Biotech:
Ulcerative Colitis, UC, 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