7 completed, 1 terminated. 3 Phase 2, 3 Phase 3, 2 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 3 | Completed 3 |
| Phase 3 | 3 | Completed 2, Terminated 1 |
| Phase 1 | 2 | Completed 2 |
Follow MOD-4023: new trials by email Literature Review of MOD-4023 trials Research Report on MOD-4023
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Safety and Efficacy Study of MOD-4023 to Treat Children With Growth Hormone Deficiency MOD-4023, Genotropin - Growth Hormone Deficiency | Phase 3 | Completed | OPKO Health, Inc. | 44 | 2017-12-07 | 2021-08-12 |
| Safety and Efficacy Phase 3 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children MOD-4023, Somatropin - Pediatric Growth Hormone Deficiency | Phase 3 | Completed | OPKO Health, Inc. | 224 | 2016-12-01 | 2025-07-20 |
| Pharmacokinetics and Pharmacodynamics of Long Acting Human Growth Hormone (hGH) Product (MOD-4023) in Healthy Caucasian and Japanese Volunteers MOD-4023, Placebo - Growth Hormone Deficiency | Phase 1 | Completed | OPKO Health, Inc. | 42 | 2015-01-01 | 2019-09-30 |
| Long Term Follow up Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children MOD-4023 - Growth Hormone Deficiency (GHD) | Phase 2 | Completed | OPKO Health, Inc. | 48 | 2014-02-01 | 2025-04-09 |
| A Phase 3, Multicenter Study To Evaluate The Efficacy And Safety Of MOD-4023 In Adults With Growth Hormone Deficiency MOD-4023, Placebo - Adult Growth Hormone Deficiency | Phase 3 | Terminated | OPKO Health, Inc. | 202 | 2013-06-01 | 2022-08-12 |
| Safety and Efficacy Phase 2 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children MOD-4023, Somatropin - Pediatric Growth Hormone Deficiency | Phase 2 | Completed | OPKO Health, Inc. | 56 | 2012-02-01 | 2020-01-23 |
| MOD-4023 (Long-Lasting Human Growth Hormone (hGH)) Study in Growth Hormone Deficient Adults (GHDA) MOD-4023 - Adult Growth Hormone Deficiency | Phase 2 | Completed | OPKO Health, Inc. | 52 | 2010-08-01 | 2019-10-08 |
| MOD-4023 Study in Healthy Male Volunteers MOD-4023 (long lasting hGH), Placebo - Healthy | Phase 1 | Completed | OPKO Health, Inc. | 24 | 2009-10-01 | 2019-09-30 |
Israel (4) · Greece (3) · Hungary (3) · United States (3) · Belarus (2) · Russia (2) · Slovakia (2) · Ukraine (2) · Argentina (1) · Australia (1) · Bulgaria (1) · Canada (1) · Colombia (1) · Czechia (1) · Georgia (1)
Zvi Zadik, MD (2) · Jacob Atsmon, M.D. (1) · Reiko Horikawa, M.D, Ph. D. (1) · Tony Cruz (1)
PMID 28323965, PMID 35405011, PMID 37955005, PMID 38053515, PMID 38717038, PMID 41183961, PMID 41879875, PMID 42372104