NCT01592500

Safety and Efficacy Phase 2 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children

Safety and Dose Finding Study of Different MOD-4023 Dose Levels Compared to Daily r-hGH Therapy in Pre-pubertal Growth Hormone Deficient Children

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: OPKO Health, Inc. · Industry
• Sex: All
• Age: 3 Years – 11 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II, open label, active-controlled, randomized safety and dose finding study of different MOD-4023 dose levels compared to daily r-hGH therapy in pre-pubertal growth hormone deficient children.

Conditions

• Pediatric Growth Hormone Deficiency

Interventions

Type	Name	Description
DRUG	MOD-4023	Once weekly subcutaneous injection
DRUG	Somatropin	Once daily subcutaneous injection of Genotropin

Timeline

• Start date: 2012-02-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2012-05-07
• Last updated: 2020-01-23
• Results posted: 2020-01-23

Locations

4 sites across 3 countries: Greece, Hungary, Slovakia