A Pharmacokinetic, Safety, and Pharmacodynamic Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome
Completed · Phase 3
Conditions studied: Short Bowel Syndrome
In brief
This will be an open label, 4-cohort study. Non-randomized subjects will receive teduglutide in each of the 3 active cohorts. An attempt will be made to enroll additional subjects into an observational cohort who will receive standard of care. Three doses of teduglutide are to be investigated for 12 weeks. All subjects will be screened prior to the start of treatment (SOT) to establish baseline characteristics including safety, eligibility and nutritional support parameters.
Key facts
- Study ID
- NCT01952080
- Run by
- Shire
- People needed
- 42
- Starts
- 2013-11-14
- Expected to finish
- 2015-01-09
- Last updated by the study team
- 2021-06-09
Who can join
Age: 1 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Children´s Hospital of Alabama — Birmingham, Alabama, United States
- Arkansas Children's Hospital — Little Rock, Arkansas, United States
- Children's Hospital Los Angeles — Los Angeles, California, United States
- Mattel Children's Hospital UCLA, Department of Pediatric Gastroenterology — Los Angeles, California, United States
- Arnold Palmer Hospital for Children — Orlando, Florida, United States
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
- Riley Hospital for Children at IU Health — Indianapolis, Indiana, United States
- Boston Children's Hospital — Boston, Massachusetts, United States
- Mott Children's Hospital, University of Michigan — Ann Arbor, Michigan, United States
- Childrens Mercy Hospitals & Clinics Pediatric Gastroenterology — Kansas City, Missouri, United States
- University of Nebraska Medical Center — Omaha, Nebraska, United States
- Montefiore Medical Center — The Bronx, New York, United States
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
- University of Tennessee Health Science Center Le Bonheur Pediatric Specialists — Memphis, Tennessee, United States
- Monroe Carell, Jr. Children's Hospital at Vanderbilt — Nashville, Tennessee, United States
- Texas Children's Hospital, Baylor College of Medicine — Houston, Texas, United States
- Seattle Childrens Hospital Gastroenterology and Hepatology — Seattle, Washington, United States
- University of Wisconsin School of Medicine and Public Health Surgery — Madison, Wisconsin, United States
- Great Ormond Street Hospital for Children — London, United Kingdom
Full record on ClinicalTrials.gov
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