A Pharmacokinetic, Safety, and Pharmacodynamic Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome
NCT ID: NCT01952080
Last Updated: 2021-06-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
42 participants
INTERVENTIONAL
2013-11-14
2015-01-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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teduglutide
Open label teduglutide, subcutaneously injected.
teduglutide
Open label intervention. Each subject will be assigned to receive 0.0125, 0.025, or 0.05 mg/kg/day for the duration of the study
Standard of Care
No interventions assigned to this group
Interventions
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teduglutide
Open label intervention. Each subject will be assigned to receive 0.0125, 0.025, or 0.05 mg/kg/day for the duration of the study
Eligibility Criteria
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Inclusion Criteria
* Short bowel syndrome that requires parenteral nutrition/intravenous (PN/IV) support
* Stable PN/IV support for at least 3 months prior to enrollment based upon the opinion of the investigator
Exclusion Criteria
* Unstable absorption due to cystic fibrosis, untreated Hirschsprung's disease or known DNA abnormalities (ie, Familial Adenomatous Polyposis, Fanconi syndrome)
* Evidence of obstruction on upper gastrointestinal (GI) series done within 6 months prior to screening
* Major gastrointestinal surgical intervention within 3 months prior to screening (insertion of feeding tube or endoscopic procedure is allowed)
1 Year
17 Years
ALL
No
Sponsors
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Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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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
Countries
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References
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Fifi A, Raphael BP, Terreri B, Uddin S, Kaufman SS. Effects of Teduglutide on Diarrhea in Pediatric Patients with Short Bowel Syndrome-Associated Intestinal Failure. J Pediatr Gastroenterol Nutr. 2023 Nov 1;77(5):666-671. doi: 10.1097/MPG.0000000000003922. Epub 2023 Aug 22.
Carter BA, Cohran VC, Cole CR, Corkins MR, Dimmitt RA, Duggan C, Hill S, Horslen S, Lim JD, Mercer DF, Merritt RJ, Nichol PF, Sigurdsson L, Teitelbaum DH, Thompson J, Vanderpool C, Vaughan JF, Li B, Youssef NN, Venick RS, Kocoshis SA. Outcomes from a 12-Week, Open-Label, Multicenter Clinical Trial of Teduglutide in Pediatric Short Bowel Syndrome. J Pediatr. 2017 Feb;181:102-111.e5. doi: 10.1016/j.jpeds.2016.10.027. Epub 2016 Nov 15.
Other Identifiers
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TED-C13-003
Identifier Type: -
Identifier Source: org_study_id
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