drugset / Trial / NCT01592500
Safety and Efficacy Phase 2 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2012-02
- Primary completion
- 2015-07
- Completion
- 2015-07
Publications
- Mauras N, Skorodok Y, Iotova V, Rosenfeld R, Wajnrajch MP, Malievskiy O, Zelinska N, Valluri SR, Zadik Z. Open-Label 9-Year Follow-Up Extension Phase 2 Study of Once-Weekly Somatrogon in Children With Growth Hormone Deficiency. J Clin Endocrinol Metab. 2026 Jun 29:dgag260. doi: 10.1210/clinem/dgag260. Online ahead of print.
- Zelinska N, Iotova V, Skorodok J, Malievsky O, Peterkova V, Samsonova L, Rosenfeld RG, Zadik Z, Jaron-Mendelson M, Koren R, Amitzi L, Raduk D, Hershkovitz O, Hart G. Long-Acting C-Terminal Peptide-Modified hGH (MOD-4023): Results of a Safety and Dose-Finding Study in GHD Children. J Clin Endocrinol Metab. 2017 May 1;102(5):1578-1587. doi: 10.1210/jc.2016-3547.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Somatrogon | Protein / enzyme biologic | 0.25 mg/kg | Subcutaneous |
| Subject | Somatrogon | Protein / enzyme biologic | 0.48 mg/kg | Subcutaneous |
| Subject | Somatrogon | Protein / enzyme biologic | 0.66 mg/kg | Subcutaneous |
| Comparator | Somatropin | Protein / enzyme biologic | 0.24 mg/kg | Subcutaneous |