Safety and Efficacy Phase 3 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children
Completed · Phase 3
Conditions studied: Pediatric Growth Hormone Deficiency
In brief
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.
Key facts
- Study ID
- NCT02968004
- Run by
- OPKO Health, Inc.
- People needed
- 224
- Starts
- 2016-12-01
- Expected to finish
- 2024-05-01
- Last updated by the study team
- 2025-07-20
Who can join
Age: 3 and older, up to 11. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Children's Hospital- Colorado — Aurora, Colorado, United States
- Rocky Mountain Pediatrics — Centennial, Colorado, United States
- Nemours Children's Health System — Jacksonville, Florida, United States
- University of Miami Medical Center — Miami, Florida, United States
- St Luke's Children's Specialty Center — Boise, Idaho, United States
- Children's Hospital of Iowa — Iowa City, Iowa, United States
- Tufts Medical Center — Boston, Massachusetts, United States
- University of Massachusettes — Worcester, Massachusetts, United States
- University of Minnesota — Minneapolis, Minnesota, United States
- The Diabetes & Obesity Clinical Specialist — Las Vegas, Nevada, United States
- Goryeb Children's Hospital — Morristown, New Jersey, United States
- Buffalo Children's Hospital — Buffalo, New York, United States
- Albert Einstein College of Medicine at Yeshiva University — Mineola, New York, United States
- Children's Hospital of Cincinnati / Cincinnati Center for Growth Disorders — Cincinnati, Ohio, United States
- Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
- Cook Children's Medical Center — Fort Worth, Texas, United States
- Mary Bridge Children's Hospital & Health Center — Tacoma, Washington, United States
- Hospital Materno Infantil San Roque — Paraná, Entre Ríos Province, Argentina
- Hospital de Ninos de la Santisima Trinidad Cordoba — Córdoba, Argentina
- John Hunter Children's Hospital — New Lambton Heights, New South Wales, Australia
- Children's Hospital at Westmead — Westmead, New South Wales, Australia
- PM Hospital for Children — Subiaco, Western Australia, Australia
- Health Institution- 2nd City Pediatric Hospital — Minsk, Belarus
- MHAT Sveta Marina — Varna, Bulgaria
- Children's Hospital of Orange County- Children's Clinic — Orange, California, United States
Full record on ClinicalTrials.gov
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