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A Multicenter, Phase 3, Randomized, Open-label, Active-controlled, Parallel-group Trial Investigating the Safety, Tolerability, and Efficacy of TransCon hGH Administered Once a Week Versus Standard Daily hGH Replacement Therapy Over 52 Weeks in Prepubertal Children With Growth Hormone Deficiency (GHD)

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Trial Profile

A Multicenter, Phase 3, Randomized, Open-label, Active-controlled, Parallel-group Trial Investigating the Safety, Tolerability, and Efficacy of TransCon hGH Administered Once a Week Versus Standard Daily hGH Replacement Therapy Over 52 Weeks in Prepubertal Children With Growth Hormone Deficiency (GHD)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Aug 2023

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At a glance

  • Drugs Lonapegsomatropin (Primary) ; Somatropin
  • Indications Somatotropin deficiency
  • Focus Registrational; Therapeutic Use
  • Acronyms heiGHT
  • Sponsors Ascendis Pharma

    • Most Recent Events

    • 18 Jun 2023 Results assessing explores IGF-1 levels, dose adjustments, and height outcomes by Tanner Stage in 3 studies heiGHt (treatment-naive trial), fliGHt (switch trial), and enliGHten (open-label extension trial), presented at the 105th Annual Meeting of the Endocrine Society.
    • 13 Jun 2023 According to an Ascendis Pharma media release, the poster including the subanalysis of tanner stage in children and adolescents with growth hormone deficiency treated with lonapegsomatropin will be presented at ENDO 2023, the annual meeting of the Endocrine Society being held June 15-18 in Chicago.
    • 12 Nov 2021 According to an Ascendis Pharma media release, European Medicine Agencys Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of a marketing authorization for Lonapegsomatropin .The European Commission final decision on the Companys MAA for TransCon hGH is expected within 67 days after the positive opinion, or by the end of January 2022.The CHMP opinion is based on results submitted in the MAA from heiGHt, fliGHt and enlighten.
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