- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00502294
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis
June 23, 2009 updated by: Facet Biotech
To compare the efficacy of visilizumab at 5 mcg/kg/day administered intravenously (IV) on Days 1 and 2 to placebo in subjects with IVSR-UC.
Study Overview
Status
Withdrawn
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
150
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Males and females, 18 years of age or older.
- Diagnosis of UC verified by endoscopy within 60 months prior to consent.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
July 13, 2007
First Submitted That Met QC Criteria
July 13, 2007
First Posted (Estimate)
July 17, 2007
Study Record Updates
Last Update Posted (Estimate)
June 25, 2009
Last Update Submitted That Met QC Criteria
June 23, 2009
Last Verified
July 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 291-416
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Intravenous Steroid-Refractory Ulcerative Colitis
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Groupe d'Etude Therapeutique des Affections Inflammatoires...CompletedUlcerative Colitis | Steroid RefractoryFrance, Spain, Belgium, Finland, Italy
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Ferring PharmaceuticalsCompletedActive Ulcerative Colitis | Remission of Ulcerative ColitisCanada
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Palatin Technologies, IncRecruitingUlcerative Colitis | Ulcerative Colitis Flare | Ulcerative Colitis Acute | UlcerativeUnited States
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Theravance BiopharmaCompletedUlcerative Colitis, Active Severe | Ulcerative Colitis, Active ModerateUnited States, Georgia, Moldova, Republic of, Romania
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Rise Therapeutics LLCUniversity of Colorado, Denver; Mayo ClinicRecruitingUlcerative Colitis | Ulcerative Colitis Chronic Moderate | Ulcerative Colitis Chronic | Ulcerative Colitis Chronic MildUnited States
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Assistance Publique - Hôpitaux de ParisMRSU 938 - Research Center of Saint AntoineNot yet recruitingPediatric Ulcerative Colitis in RemissionFrance
-
Protagonist Therapeutics, Inc.CompletedUlcerative Colitis Chronic Moderate | Ulcerative Colitis Chronic SevereUnited States, Austria, Bulgaria, Canada, Georgia, Germany, Hungary, Italy, Korea, Republic of, Poland, Russian Federation, Serbia, Ukraine
-
Theravance BiopharmaCompletedActive Mild Ulcerative Colitis, Active Moderate Ulcerative Colitis, Healthy SubjectsUnited States
-
Altheus Therapeutics, Inc.UnknownUlcerative Colitis | Left-sided Ulcerative Colitis | Distal Ulcerative ColitisUnited States
-
Academisch Medisch Centrum - Universiteit van Amsterdam...University Medical Center Groningen; UMC UtrechtRecruitingUlcerative Colitis | Ulcerative Colitis Flare | Ulcerative Colitis AcuteNetherlands
Clinical Trials on Visilizumab (HuM291; Nuvion®)
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PDL BioPharma, Inc.TerminatedUlcerative ColitisBelgium, France, United States, Italy, Australia, Czech Republic, Netherlands, Ireland, Norway, Canada, Austria, Germany, Hungary, Ukraine
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AbbottTerminatedUlcerative ColitisUnited States, Canada, Croatia, Italy, Russian Federation, Spain