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

NCT00279435 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2012-03-12

No results posted yet for this study

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.

Conditions

Interventions

DRUG

visilizumab

Sponsors & Collaborators

  • PDL BioPharma, Inc.

    collaborator INDUSTRY

  • Facet Biotech

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2007-08-31
Completion
2007-08-31

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • Croatia
  • Czechia
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Netherlands
  • Norway
  • Ukraine

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00279435 on ClinicalTrials.gov