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

NCT ID: NCT02682381


Title
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
Purpose
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.
Details
Conditions
Short Bowel Syndrome
Keywords
Teduglutide, pediatric, GLP-2, parenteral support, Short Bowel Syndrome, short gut syndrome, short gut, SBS, parenteral nutrition
Source
Shire
Sponsors
Shire
Status
Recruiting
Acronym
Last Updated
25 Jan 2017
URL
Official Link
Locations
Belgium, Canada, Finland, France, Germany, Italy, United Kingdom, United States