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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

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Trial Profile

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 of Trial: Phase III

Latest Information Update: 20 Nov 2023

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At a glance

  • Drugs Teduglutide (Primary)
  • Indications Short bowel syndrome
  • Focus Registrational; Therapeutic Use
  • Sponsors Shire

    • Most Recent Events

    • 01 Nov 2023 Results of pooled post hoc analysis from NCT01952080 and NCT02682381 assessing the effect of teduglutide treatment on diarrhea in patients with short bowel syndrome-associated intestinal failure published in the Journal of Pediatric Gastroenterology and Nutrition
    • 17 May 2019 According to a Takeda media release, the U.S. Food and Drug Administration (FDA) approved extending the indication of GATTEX (teduglutide) for injection to pediatric patients 1 year of age and older with Short Bowel Syndrome (SBS) who need additional nutrition or fluids from intravenous (IV) feeding (parenteral support).
    • 30 Nov 2018 France was a planned location for this trial.

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