NCT02500316

Long Term Follow up 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-human Growth Hormone (hGH) Therapy in Pre-pubertal Growth Hormone Deficient Children

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: OPKO Health, Inc. · Industry
• Sex: All
• Age: 3 Years – 11 Years
• Healthy volunteers: Not accepted

Summary

Protocol CP-4-004-OLE (Open Label Extension) is designed as a long-term, open-label extension using single patient use, multi-dose, disposable pre-filled pen.

Conditions

• Growth Hormone Deficiency (GHD)

Interventions

Type	Name	Description
DRUG	MOD-4023	Once weekly injection of long acting r-hGH (MOD-4023) provided as a solution for injection containing 20 or 50 mg/mL MOD-4023 in a single patient use, multi-dose, disposable pre-filled pen (PEN).

Timeline

• Start date: 2014-02-01
• Primary completion: 2023-11-01
• Completion: 2023-11-01
• First posted: 2015-07-16
• Last updated: 2025-04-09
• Results posted: 2025-04-09

Locations

13 sites across 6 countries: United States, Belarus, Greece, Hungary, Russia, Ukraine