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A Long-Term, Open-Label Study With Teduglutide for Subjects With Parenteral Nutrition Dependent Short Bowel Syndrome

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Trial Profile

A Long-Term, Open-Label Study With Teduglutide for Subjects With Parenteral Nutrition Dependent Short Bowel Syndrome

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 25 Jul 2022

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At a glance

  • Drugs Teduglutide (Primary)
  • Indications Short bowel syndrome
  • Focus Registrational; Therapeutic Use
  • Acronyms STEPS-2
  • Sponsors NPS Pharmaceuticals

    • Most Recent Events

    • 01 Jun 2022 According to a Takeda media release, the National Institute for Health and Care Excellence (NICE), has published its Final Appraisal Document (FAD) recommending Revestive (teduglutide) once daily subcutaneous injection as an option for people living with Short Bowel Syndrome (SBS) aged 1 year and above. Key evidence behind the NICE recommendation was data from the STEPS and STEPS-2 trials.
    • 24 May 2017 Results of post hoc analysis assessing relationship between days and volume of parenteral nutrition using patient data from STEPS and STEPS-2 trials, presented at the 22nd Annual International Meeting of the International Society for Pharmacoeconomics and Outcomes Research
    • 19 Oct 2016 Results (n=43) from STEPS and STEPS-2 studies assessing predictors of response presented at the 24th United European Gastroenterology Week.

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