Status:
COMPLETED
Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome Who Completed Protocol CL0600-004 (NCT00081458)
Lead Sponsor:
Shire
Conditions:
Short Bowel Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this clinical study is to evaluate the long-term safety and efficacy of daily administration of teduglutide.
Detailed Description
Teduglutide is an analog of naturally occurring human glucagon-like peptide-2 (GLP-2), a peptide secreted by L-cells of the distal intestine. GLP-2 is known to increase intestinal and portal blood flo...
Eligibility Criteria
Inclusion
- At dosing week 24 of protocol CL0600-004 (NCT00081458), subjects will be reviewed for their participation in this study.
- Subjects who meet all of the following criteria can be enrolled in this study:
- Signed and dated informed consent form (ICF) to participate before any study-related procedures are performed
- Completion of protocol CL0600-004 (NCT00081458)
Exclusion
- History of cancer or clinically significant lymphoproliferative disease with fewer than 5 years documented disease-free state
- History of alcohol or drug abuse (within previous year)
- Prior use of native glucagon-like peptide 2 (GLP-2) within 3 months of screening visit
- Pregnant or lactating women
- Any condition or circumstance, which in the investigator's opinion would put the subject at any undue risk, prevent completion of the study, or interfere with analysis of the study results
Key Trial Info
Start Date :
January 10 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 24 2008
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00172185
Start Date
January 10 2005
End Date
January 24 2008
Last Update
June 2 2021
Active Locations (21)
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1
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259
2
Emory University Hospital
Atlanta, Georgia, United States, 30322
3
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
4
Albany Medical Center
Albany, New York, United States, 12208