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

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

Completed
Phase of Trial: Phase III

Latest Information Update: 15 Nov 2016

At a glance

  • Drugs Teduglutide (Primary)
  • Indications Short bowel syndrome
  • Focus Adverse reactions; Pharmacodynamics
  • Sponsors NPS Pharmaceuticals
  • Most Recent Events

    • 15 Nov 2016 Results published in the Journal of Pediatrics.
    • 07 Jul 2016 Results published in the Media Release
    • 07 Jul 2016 According to a Shire media release, based on the data from this trial and the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) positive opinion, the European Commission has granted extension of Market Authorization for teduglutide for the treatment of Short Bowel Syndrome (SBS) in patients aged one year and above
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