NCT02682381

Short Bowel Syndrome Research Study for Children Up To 17 Years of Age on Parenteral Nutrition

A 24-Week Double-blind, Safety, Efficacy, and Pharmacodynamic Study Investigating Two Doses of Teduglutide in Pediatric Subjects Through 17 Years of Age With Short Bowel Syndrome Who Are Dependent on Parenteral Support

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 0 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

Teduglutide is approved for treatment of adults with short bowel syndrome (SBS). The purpose of this study is to evaluate the safety and efficacy of teduglutide in children up to the age of 17 with SBS who are dependent on parenteral support. Subjects may choose whether to receive the study drug or to participate in a standard-of-care arm. All participants who complete the study may be eligible to receive the study drug in a long-term extension study.

Conditions

• Short Bowel Syndrome

Interventions

Type	Name	Description
DRUG	Teduglutide 0.05mg/kg	0.05 mg/kg
DRUG	Teduglutide 0.025 mg/kg	0.025 mg/kg
OTHER	Standard of Care	Observational cohort for the 24-week treatment period and 4 week follow-up.

Timeline

• Start date: 2016-06-23
• Primary completion: 2017-08-18
• Completion: 2017-08-18
• First posted: 2016-02-15
• Last updated: 2021-06-09
• Results posted: 2018-10-16

Locations

27 sites across 7 countries: United States, Belgium, Canada, Finland, Germany, Italy, United Kingdom