Long-term Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome Who Completed the TED-C13-003 Study

Completed · Phase 3

Conditions studied: Short Bowel Syndrome

In brief

The purpose of this study is to evaluate the safety and efficacy of teduglutide treatment of children with short bowel syndrome (SBS) who completed the TED-C13-003 study over a long-term period. It will evaluate how these children fared after the TED-C13-003 study ended. This study will also offer teduglutide treatment to eligible subjects, regardless of treatment received in TED-C13-003.

Key facts

Study ID

NCT02949362

Run by

Shire

People needed

29

Starts

2016-12-09

Expected to finish

2020-07-14

Last updated by the study team

2025-03-19

Who can join

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

You may qualify if…

• Subject provides written informed consent (subject, parent or legal guardian and, as appropriate, subject informed assent) to participate in the study before completing any study-related procedures.
• Subject completed the TED-C13-003 study (including subjects in the standard of care treatment arm).
• Subject 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
• 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

Full record on ClinicalTrials.gov

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