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A 12-Week Pharmacokinetic, Safety, and Pharmacodynamic Study of Teduglutide in Paediatric Subjects Aged 1 Year Through 17 Years, With Short Bowel Syndrome Who Are Dependent on Parenteral Support

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Trial Profile

A 12-Week Pharmacokinetic, Safety, and Pharmacodynamic Study of Teduglutide in Paediatric Subjects Aged 1 Year Through 17 Years, With Short Bowel Syndrome Who Are Dependent on Parenteral Support

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Nov 2023

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At a glance

  • Drugs Teduglutide (Primary)
  • Indications Short bowel syndrome
  • Focus Therapeutic Use
  • Sponsors NPS Pharmaceuticals
  • 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).
    • 13 Nov 2018 According to a Shire media release, the U.S. Food and Drug Administration (FDA) has accepted for filing the supplemental new drug application to extend the indication of GATTEX (teduglutide [rDNA origin]) for injection to paediatric patients (aged 1-17 years old) with Short Bowel Syndrome (SBS) who are dependent on parenteral support. The company submitted the sNDA on September 11, 2018 and the FDA decision is expected in March 2019.
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