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

NCT ID: NCT00355901

Last Updated: 2008-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-09-30

Study Completion Date

2012-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Ulcerative Colitis

Keywords

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Ulcerative Colitis Colitis Steroid-Refractory Visilizumab Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC)

Study Design

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Study Time Perspective

PROSPECTIVE

Interventions

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Visilizumab (Nuvion®; HuM291)

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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PDL BioPharma, Inc.

INDUSTRY

Sponsor Role lead

Locations

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San Francisco, California, United States

Site Status

Gainesville, Florida, United States

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Atlanta, Georgia, United States

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Louisville, Kentucky, United States

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Worcester, Massachusetts, United States

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Rochester, Minnesota, United States

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St Louis, Missouri, United States

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Manhasset, New York, United States

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Mineola, New York, United States

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New York, New York, United States

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New York, New York, United States

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Cleveland, Ohio, United States

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Hershey, Pennsylvania, United States

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Charleston, South Carolina, United States

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Salt Lake City, Utah, United States

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Bedford Park, South Australia, Australia

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Box Hill, Victoria, Australia

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Fremantle, , Australia

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Liverpool, , Australia

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Vienna, , Austria

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Ghent, , Belgium

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Leuven, , Belgium

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Roeselare, , Belgium

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Winnipeg, Manitoba, Canada

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Hamilton, Ontario, Canada

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Brno, , Czechia

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Prague, , Czechia

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Amiens, , France

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Lille, , France

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Paris, , France

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Freiburg im Breisgau, , Germany

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Béri Balogh Adám, , Hungary

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Vác, , Hungary

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Vásvari Pál, , Hungary

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Dublin, , Ireland

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Bologna, , Italy

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Amsterdam, , Netherlands

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Oslo, , Norway

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Tromsø, , Norway

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Kharkiv, , Ukraine

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Countries

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United States Australia Austria Belgium Canada Czechia France Germany Hungary Ireland Italy Netherlands Norway Ukraine

Other Identifiers

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291-420

Identifier Type: -

Identifier Source: org_study_id