Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC)
NCT00307827 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38
Last updated 2012-04-27
Summary
The purpose of this study is to assess the efficacy, immunogenicity, and safety of various doses of visilizumab in subjects with intravenous steroid-refractory ulcerative colitis (IVSR-UC) and to evaluate optimal dosing.
Conditions
Interventions
- DRUG
-
Visilizumab
Visilizumab administered intravenously once per day for two days
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Mihail Obrocea, MD · Abbott
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-04-30
- Primary Completion
- 2007-11-30
- Completion
- 2007-11-30
Countries
- United States
- Canada
- Croatia
- Italy
- Russia
- Spain
Study Locations
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