A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis
NCT00502294 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2009-06-25
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.
Conditions
- Intravenous Steroid-Refractory Ulcerative Colitis
Interventions
- DRUG
-
Visilizumab (HuM291; Nuvion®)
Sponsors & Collaborators
-
PDL BioPharma, Inc.
collaborator INDUSTRY -
Facet Biotech
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
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