Status:
TERMINATED
An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis
Lead Sponsor:
PDL BioPharma, Inc.
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Brief Summary
To assess the effects of visilizumab on the safety of subsequent salvage therapies in subjects who experienced disease progression in a previous visilizumab study and subsequently received salvage the...
Eligibility Criteria
Inclusion
- Previous participation in a visilizumab study of IVSR-UC.
- Disease progression while enrolled in a previous visilizumab study, and subsequent treatment with salvage therapy.
Exclusion
- Unable to understand the purpose and risks of the study, or unwilling or unable to provide a signed and dated informed consent.
- For U.S. sites, unwilling or unable to provide authorization to use protected health information.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2012
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00355901
Start Date
September 1 2006
End Date
November 1 2012
Last Update
August 5 2008
Active Locations (40)
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1
San Francisco, California, United States, 94115
2
Gainesville, Florida, United States, 32610
3
Atlanta, Georgia, United States, 30342
4
Louisville, Kentucky, United States, 40202