Long-term Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome Who Completed the TED-C13-003 Study
NCT ID: NCT02949362
Last Updated: 2025-03-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
29 participants
INTERVENTIONAL
2016-12-09
2020-07-14
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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Standard of Care (SOC) Treatment +/- Teduglutide
TED 0.05mg/kg subcutaneous injections once daily as needed in addition to SOC treatment
Teduglutide
0.05mg/kg
SOC
Standard safety assessments and adjustments in nutritional support will be provided for all subjects throughout the study, including any teduglutide treatment periods
Interventions
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Teduglutide
0.05mg/kg
SOC
Standard safety assessments and adjustments in nutritional support will be provided for all subjects throughout the study, including any teduglutide treatment periods
Eligibility Criteria
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Inclusion Criteria
2. Subject completed the TED-C13-003 study (including subjects in the standard of care treatment arm).
3. Subject understands and is willing and able to fully adhere to study requirements as defined in this protocol.
ALL
No
Sponsors
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Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Shire Study Physician
Role: PRINCIPAL_INVESTIGATOR
Shire
Locations
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Childrens Hospital Los Angeles - RHU
Los Angeles, California, United States
Mattel Children's Hospital UCLA
Los Angeles, California, United States
Riley Hospital for Children
Indianapolis, Indiana, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States
Children's Hospital at Montefiore
The Bronx, New York, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Texas Children's Hospital
Houston, Texas, United States
Seattle Children's Hospital
Seattle, Washington, United States
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, United States
Great Ormond Children's Hospital
London, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain more information on the study, click here/on this link
Other Identifiers
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2016-000863-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SHP633-303
Identifier Type: -
Identifier Source: org_study_id
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