clinical trial · NCT02968004
Safety and Efficacy Phase 3 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children
Pediatric Growth Hormone DeficiencyMOD-4023Somatropin
brief summary
This is an open-label, randomized, multicenter, efficacy and safety study of weekly MOD-4023 compared to daily Genotropin therapy in pre-pubertal children with growth hormone deficiency.
started
Dec 1, 2016
primary completion
Aug 1, 2019
completion
May 1, 2024
last updated
Jul 20, 2025
detailed description
The study consists of a 12 month, open-label, randomized, active controlled, parallel group study comparing the efficacy and safety of weekly MOD-4023 to daily growth hormone (GH), Genotropin. After 12 months, subjects will have the option to enter the long term open-label extension.
official title
A Phase 3, Open-label, Randomized, Multicenter, 12 Months, Efficacy and Safety Study of Weekly MOD-4023 Compared to Daily Genotropin - Therapy in Pre-pubertal Children With Growth Hormone Deficiency
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol