A Randomized, Phase 2/3, Open-Label, Multi-center Study of the Pharmacokinetics, Pharmacodynamics, Safety and Efficacy of A Long-acting Human Growth Hormone (Somavaratan, VRS-317) in Pre-pubertal Japanese Children With Growth Hormone Deficiency (GHD)

Trial Profile

A Randomized, Phase 2/3, Open-Label, Multi-center Study of the Pharmacokinetics, Pharmacodynamics, Safety and Efficacy of A Long-acting Human Growth Hormone (Somavaratan, VRS-317) in Pre-pubertal Japanese Children With Growth Hormone Deficiency (GHD)

Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 27 Apr 2017

At a glance

  • Drugs Somavaratan (Primary)
  • Indications Growth disorders; Somatotropin deficiency
  • Focus Registrational; Therapeutic Use
  • Sponsors Versartis
  • Most Recent Events

    • 07 Jun 2017 Biomarkers information updated
    • 27 Apr 2017 According to a Versartis media release, the company anticipates to complete enrollment in the phase III portion of the trial in the second half of 2017.
    • 04 Apr 2017 Results (n=48) comapring PK/PD properties of somavaratan in USA and Japan prepubertal children using patient data from VERTICAL and J14VR5 trials, presented at The 99th Annual Meeting of the Endocrine Society
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