A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis
Sponsor
Facet Biotech (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT00502294
Collaborator
PDL BioPharma, Inc. (Industry)
150
Study Details
Study Description
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 |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Anticipated 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
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
No locations specified.Sponsors and Collaborators
- Facet Biotech
- PDL BioPharma, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00502294
Other Study ID Numbers:
- 291-416
First Posted:
Jul 17, 2007
Last Update Posted:
Jun 25, 2009
Last Verified:
Jul 1, 2008
Keywords provided by ,
,
Additional relevant MeSH terms: