NCT00279435

Study of Visilizumab Versus Placebo in Subjects With Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study

A Randomized, Double-blind, Multicenter Study of Visilizumab Versus Placebo in Subjects With Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Facet Biotech · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	visilizumab

Timeline

• Start date: 2006-08-01
• Primary completion: 2007-08-01
• Completion: 2007-08-01
• First posted: 2006-01-19
• Last updated: 2012-03-12

Locations

39 sites across 15 countries: United States, Australia, Austria, Belgium, Canada, Croatia, Czechia, France, Germany, Hungary, Israel, Italy, Netherlands, Norway, Ukraine