Study of Visilizumab Versus Placebo in Subjects With Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study
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|ClinicalTrials.gov Identifier: NCT00279435|
Recruitment Status : Terminated (company decision based on other studies)
First Posted : January 19, 2006
Last Update Posted : March 12, 2012
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis||Drug: visilizumab||Phase 2 Phase 3|
The purpose of this study is to compare the efficacy, safety, pharmacokinetics, and immunogenicity in subjects retreated with visilizumab or placebo after a response in a prior visilizumab study.
PDL BioPharma, Inc. was formerly known as Protein Design Labs, Inc.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-blind, Multicenter Study of Visilizumab Versus Placebo in Subjects With Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study|
|Study Start Date :||August 2006|
|Actual Primary Completion Date :||August 2007|
|Actual Study Completion Date :||August 2007|
|Placebo Comparator: placebo||Drug: visilizumab|
|Experimental: visilizumab||Drug: visilizumab|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00279435
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