Intravenous Steroid-Refractory Ulcerative Colitis Clinical Trial
Official title:
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis
| NCT number | NCT00502294 |
| Other study ID # | 291-416 |
| Secondary ID | |
| Status | Withdrawn |
| Phase | Phase 3 |
| First received | July 13, 2007 |
| Last updated | June 23, 2009 |
| Verified date | July 2008 |
| Source | Facet Biotech |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Withdrawn |
| Enrollment | 150 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Males and females, 18 years of age or older. - Diagnosis of UC verified by endoscopy within 60 months prior to consent. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Facet Biotech | PDL BioPharma, Inc. |