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This study has been withdrawn prior to enrollment.
PDL BioPharma, Inc.
Information provided by:
First received: July 13, 2007
Last updated: June 23, 2009
Last verified: July 2008
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.
Intravenous Steroid-Refractory Ulcerative Colitis
Drug: Visilizumab (HuM291; Nuvion®)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
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:
U.S. FDA Resources
Further study details as provided by Facet Biotech:
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