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This study has been withdrawn prior to enrollment.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:
Collaborator:
PDL BioPharma, Inc.
Information provided by:
Facet Biotech
ClinicalTrials.gov Identifier:
NCT00502294
First received: July 13, 2007
Last updated: June 23, 2009
Last verified: July 2008
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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.

No Contacts or Locations Provided
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00502294     History of Changes
Other Study ID Numbers: 291-416
Study First Received: July 13, 2007
Last Updated: June 23, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Facet Biotech:
Ulcerative Colitis, UC, 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 28, 2014