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Sponsored by: |
PDL BioPharma, Inc. |
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Information provided by: | Facet Biotech |
ClinicalTrials.gov Identifier: | NCT00279435 |
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.
Condition | Intervention |
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Ulcerative Colitis |
Drug: Visilizumab (Nuvion®; HuM291) |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 80 |
Study Start Date: | August 2006 |
Estimated Study Completion Date: | February 2010 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | 291-417 |
Study First Received: | January 17, 2006 |
Last Updated: | January 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00279435 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Intravenous, Steroid-Refractory, Ulcerative Colitis |
Digestive System Diseases Gastrointestinal Diseases Ulcer Colonic Diseases Inflammatory Bowel Diseases |
Colitis, Ulcerative Intestinal Diseases Gastroenteritis Colitis |
Pathologic Processes Digestive System Diseases Gastrointestinal Diseases Ulcer Colonic Diseases |
Inflammatory Bowel Diseases Colitis, Ulcerative Intestinal Diseases Gastroenteritis Colitis |