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A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00502294
First Posted: July 17, 2007
Last Update Posted: June 25, 2009
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.
Collaborator:
PDL BioPharma, Inc.
Information provided by:
Facet Biotech
  Purpose
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 Intervention Phase
Intravenous Steroid-Refractory Ulcerative Colitis Drug: Visilizumab (HuM291; Nuvion®) Phase 3

Study Type: Interventional
Study Design: 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 NLM:


Further study details as provided by Facet Biotech:

Estimated Enrollment: 150
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00502294     History of Changes
Other Study ID Numbers: 291-416
First Submitted: July 13, 2007
First Posted: July 17, 2007
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