NCT02968004

Safety and Efficacy Phase 3 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 224 (actual)
• Sponsor: OPKO Health, Inc. · Industry
• Sex: All
• Age: 3 Years – 11 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Pediatric Growth Hormone Deficiency

Interventions

Type	Name	Description
DRUG	MOD-4023	Once weekly subcutaneous injection using pre-filled pen device.
DRUG	Somatropin	Once daily subcutaneous injection of Genotropin using pre-filled pen device.

Timeline

• Start date: 2016-12-01
• Primary completion: 2019-08-01
• Completion: 2024-05-01
• First posted: 2016-11-18
• Last updated: 2025-07-20
• Results posted: 2021-06-25

Locations

81 sites across 20 countries: United States, Argentina, Australia, Belarus, Bulgaria, Canada, Colombia, Georgia, Greece, India, Israel, Mexico, New Zealand, Poland, Russia, South Korea, Spain, Taiwan, Ukraine, United Kingdom