Long-term Safety and Efficacy Study of Teduglutide in Pediatric Participants With Short Bowel Syndrome (SBS)
NCT ID: NCT02954458
Last Updated: 2025-03-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
61 participants
INTERVENTIONAL
2017-01-09
2020-11-05
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)
Participants will receive 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily into 1 of the 4 quadrants of the abdomen or into either the thigh or arm as needed in addition to SOC treatment.
TED
0.05 mg/kg SC injection once daily.
SOC
Standard safety assessments and adjustments in nutritional support.
Syringe
Teduglutide will be administered using syringe.
Needle
Teduglutide will be administered using needle.
Interventions
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TED
0.05 mg/kg SC injection once daily.
SOC
Standard safety assessments and adjustments in nutritional support.
Syringe
Teduglutide will be administered using syringe.
Needle
Teduglutide will be administered using needle.
Eligibility Criteria
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Inclusion Criteria
2. Participant completed the TED-C14-006 or SHP633-301 studies (including participants in the standard of care treatment arms). Participants are considered to have completed SHP633-301 if they completed study assessments through week 24.
3. Participant 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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Study Director
Role: STUDY_DIRECTOR
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
UCSF Benioff Children's Hospital
San Francisco, California, United States
Georgetown Children's Research Network
Washington D.C., District of Columbia, United States
Riley Hospital for Children
Indianapolis, Indiana, United States
Boston Children's Hospital
Boston, Massachusetts, United States
The Nebraska Medical Center
Omaha, Nebraska, United States
Columbia Unversity Medical Center
New York, New York, United States
Children's Hosp. at Montefiore
The Bronx, New York, United States
Duke Medical Center
Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 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
Cliniques Universitaires Saint-Luc
Brussels, Woluwe-Saint-Lambert, Belgium
Walter C. Mackenzie Health Science Centre
Edmonton, Alberta, Canada
The Hospital for Sick Children
Toronto, Ontario, Canada
Helsingin yliopistollinen keskussairaala
Helsinki, , Finland
Ospedale Pediatrico Bambino Gesu
Roma, , Italy
Great Ormond Children's Hosp
London, Greater London, United Kingdom
Birmingham Children's Hospital
Birmingham, West Midlands, 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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2016-000849-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SHP633-304
Identifier Type: -
Identifier Source: org_study_id
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