DRUG
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
A Pharmacokinetic, Safety, and Pharmacodynamic Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome
Status
Completed
Phase
Phase 3
Enrollment
42
Locations
19
Results
Posted
Publications
2
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Sep 27, 2013
Study start
Nov 14, 2013
Primary completion
Jan 9, 2015
Study completion
Jan 9, 2015
Results posted
Sep 14, 2015
Registry updated
Jun 9, 2021
Outcomes
What the study measures.
Primary outcomes
Percent Change in Parenteral Support [Parenteral Nutrition (PN)/Intravenous (IV)] Volume at Week 12
Time frame · Baseline, Week 12
Percent change in PN/IV from the Baseline Visit to Week 12 Visit.
Percent Change in Parenteral Support (PN/IV) Volume at End of Treatment
Time frame · Baseline, End of Treatment
Percent change in PN/IV from the Baseline Visit to End of Treatment Visit.
Percent Change in Parenteral Support (PN/IV) Volume at Week 16
Time frame · Baseline, Week 16
Percent change in PN/IV from the Baseline Visit to Week 16 Visit.
Absolute Change in Parenteral Support (PN/IV) Volume at Week 12
Time frame · Baseline, Week 12
Absolute change in PN/IV from the Baseline Visit to Week 12 Visit.
Absolute Change in Parenteral Support (PN/IV) Volume at End of Treatment
Time frame · Baseline, End of Treatment
Absolute change in PN/IV from the Baseline Visit to End of Treatment Visit.
Absolute Change in Parenteral Support (PN/IV) Volume at Week 16
Time frame · Baseline, Week 16
Absolute change in PN/IV from the Baseline Visit to Week 16 Visit.
Secondary outcomes
Not reported in the indexed record.
Eligibility
Who can take part.
- Minimum age
- 1 Year
- Maximum age
- 17 Years
- Sex
- ALL
- Healthy volunteers
- No
Key Inclusion Criteria: * Current history of SBS as a result of major intestinal resection, (eg, due to necrotizing enterocolitis, midgut volvulus, intestinal atresia, or gastroschisis) for at least 12 months prior to screening * 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 Key Exclusion Criteria: * Serial transverse enteroplasty or any other bowel lengthening procedure performed within the past 3 months * 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)
Study locations
19 registered sites.
United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.
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
Publications
Results and literature.
PMID 37889619 ↗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.PMID 27855998 ↗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.
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Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.