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)

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)

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 17 Jan 2018

At a glance

  • Drugs ACP 001 (Primary)
  • Indications Somatotropin deficiency
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms heiGHT
  • Sponsors Ascendis Pharma
  • Most Recent Events

    • 03 Jan 2018 According to an Ascendis Pharma media release, the company expects to randomize over 160 subjects and based on one-year follow-up, top-line results are anticipated in the first quarter of 2019.
    • 03 Jan 2018 Status changed from recruiting to active, no longer recruiting, according to an Ascendis Pharma media release.
    • 04 Apr 2017 Trial design and rationale presented at The 99th Annual Meeting of the Endocrine Society
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