Long-term Safety and Efficacy Study of Teduglutide in Pediatric Participants With Short Bowel Syndrome (SBS)

Completed · Phase 3

Conditions studied: Short Bowel Syndrome

In brief

This study will follow participants who completed the TED-C14-006 study. The purpose of this study is to evaluate the long-term safety and efficacy of teduglutide in pediatric participants with Short Bowel Syndrome (SBS). This study will also offer teduglutide treatment to eligible participants, regardless of treatment received in TED-C14-006 or SHP633-301.

Key facts

Study ID

NCT02954458

Run by

Shire

People needed

61

Starts

2017-01-09

Expected to finish

2020-11-05

Last updated by the study team

2025-03-28

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant provides written informed consent (participant, parent or legal guardian and, as appropriate, informed assent) to participate in the study before completing any study-related procedures.
• 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.
• Participant understands and is willing and able to fully adhere to study requirements as defined in this protocol.

You may not qualify if…

• There are no exclusion criteria for this study.

Where it is running

• 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

Full record on ClinicalTrials.gov

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