Safety and Efficacy of ALX-0600 in Subjects With Active Crohn's Disease Who Completed Protocol CL0600-008
NCT ID: NCT00308438
Last Updated: 2021-05-14
Study Results
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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COMPLETED
PHASE2
67 participants
INTERVENTIONAL
2004-03-01
2006-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
All subjects in the study dosed at 0.1 mg/kg teduglutide
Teduglutide (ALX-0600)
0.1 mg/kg injected subcutaneously daily
Interventions
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Teduglutide (ALX-0600)
0.1 mg/kg injected subcutaneously daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* CDAI score greater than 220
* Stool samples not required
* C-reactive protein levels are not an exclusion criterion
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Advanced Clinical Therapeutics
Tucson, Arizona, United States
Rocky Mountain Gastroenterology
Lakewood, Colorado, United States
Rx Trials
Washington D.C., District of Columbia, United States
Clinical Trials Management of Boca Raton
Boca Raton, Florida, United States
Clinical Research of West Florida
Clearwater, Florida, United States
Venture Research
North Miami Beach, Florida, United States
Pinnacle Trials
Atlanta, Georgia, United States
Saint Joseph's Health System
Atlanta, Georgia, United States
Northwestern University School of Medicine
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
University of Louisville
Louisville, Kentucky, United States
Long Island Clinical Research Associates
Great Neck, New York, United States
Asher Kornbluth, MD, PC
New York, New York, United States
Wake Research Associates
Raleigh, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Atilla Ertan
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
McGuire DVAMC
Richmond, Virginia, United States
Dean Foundation Research Center
Madison, Wisconsin, United States
Vancouver General Hospital
Vancouver, British Columbia, Canada
Health Sciences Center
Winnipeg, Manitoba, Canada
Queen Elizabeth II Health Sciences
Halifax, Nova Scotia, Canada
Life Screening Centres
Toronto, Ontario, Canada
Countries
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References
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Buchman AL, Katz S, Fang JC, Bernstein CN, Abou-Assi SG; Teduglutide Study Group. Teduglutide, a novel mucosally active analog of glucagon-like peptide-2 (GLP-2) for the treatment of moderate to severe Crohn's disease. Inflamm Bowel Dis. 2010 Jun;16(6):962-73. doi: 10.1002/ibd.21117.
Other Identifiers
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CL0600-009
Identifier Type: -
Identifier Source: org_study_id
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