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NCT00355901 Clinical Trial

An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Official title:
An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00355901
Other study ID # 291-420
Secondary ID
Status Terminated
Phase Phase 2
First received July 21, 2006
Last updated August 2, 2008
Start date September 2006
Est. completion date November 2012

Study information
Verified date August 2008
Source Facet Biotech
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial 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 therapy.

Recruitment information / eligibility
Status Terminated
Enrollment 300
Est. completion date November 2012
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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 Criteria:

- 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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Visilizumab (Nuvion®; HuM291)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
PDL BioPharma, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  Czech Republic,  France,  Germany,  Hungary,  Ireland,  Italy,  Netherlands,  Norway,  Ukraine, 

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