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Clinical Trial Summary

This will be 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.


Clinical Trial Description

The study will consist 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02968004
Study type Interventional
Source OPKO Health, Inc.
Contact
Status Active, not recruiting
Phase Phase 3
Start date December 2016
Completion date June 2024

See also
  Status Clinical Trial Phase
Completed NCT01718041 - Versartis Trial in Children to Assess Long-Acting Growth Hormone Phase 1/Phase 2
Terminated NCT02068521 - Versartis Long-Term Safety Study of Somavaratan Phase 2/Phase 3
Not yet recruiting NCT05509894 - Korean Post-marketing Surveillance Ngenla® Pre-filled Pen Injection for the Treatment of Pediatric Patients With Growth Disturbance Due to Insufficient Secretion of Growth Hormone
Completed NCT04633057 - A Study to Evaluating the Efficacy and Safety of Recombinant Long-acting Human Growth Hormone (TJ101) in Children With Growth Hormone Deficiency Phase 3
Withdrawn NCT06113952 - A Study to Compare the Experiences of Taking Daily Growth Hormone Injections to Weekly Ngenla in Children With Low Levels of Growth Hormone
Completed NCT01592500 - Safety and Efficacy Phase 2 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children Phase 2
Terminated NCT02413138 - Versartis Trial in Pre-pubertal Japanese Children With Growth Hormone Deficiency (GHD) to Assess Long-Acting Growth Hormone (Somavaratan, VRS-317) Phase 2/Phase 3