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Sponsored by: |
PDL BioPharma, Inc. |
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Information provided by: | PDL BioPharma, Inc. |
ClinicalTrials.gov Identifier: | NCT00307827 |
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.
Condition | Intervention | Phase |
---|---|---|
Ulcerative Colitis |
Drug: Visilizumab (Nuvion®; HuM291) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2, Randomized, Double-Blind, Multicenter, Dose-Exploration Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Eligible subjects will be considered for inclusion in this study if they meet all of the following criteria:
Exclusion Criteria:
Subjects will be ineligible for this study if they meet any one of the following criteria:
Study ID Numbers: | 291-418 |
Study First Received: | March 24, 2006 |
Last Updated: | July 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00307827 |
Health Authority: | United States: Food and Drug Administration |
Steroid-Refractory, IVSR-UC, Ulcerative Colitis |
Digestive System Diseases Gastrointestinal Diseases Ulcer Colonic Diseases Inflammatory Bowel Diseases |
Colitis, Ulcerative Intestinal Diseases Gastroenteritis Colitis |
Pathologic Processes |