Somatrogon (genetical recombination) (DrugBank: Somatrogon)
1 disease| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 78 | Hypopituitarism | 1 |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | JPRN-JapicCTI-183963 | 25/12/2017 | 17/05/2018 | Safety and Efficacy Study of MOD-4023 to Treat Children With Growth Hormone Deficiency | A PHASE 3, OPEN-LABEL, RANDOMIZED, MULTICENTER, 12-MONTH, EFFICACY AND SAFETY STUDY OF WEEKLY MOD-4023 COMPARED TO DAILY GENOTROPIN THERAPY IN JAPANESE PRE-PUBERTAL CHILDREN WITH GROWTH HORMONE DEFICIENCY | Treatment of children with growth failure due to growth hormone deficiency (GHD) | Intervention name : Somatrogon (Genetical Recombination) INN of the intervention : somatrogon Dosage And administration of the intervention : MOD-4023 (investigational treatment): weekly MOD-4023 SC injections for 12 months; initially over the first 6 weeks, MOD-4023 will be administered in 3 stepwise escalating doses (0.25 mg/kg/week, 0.48 mg/kg/week and 0.66 mg/kg/week), each for two weeks sequentially. For the remaining 46 weeks, patients will continue to receive MOD-4023 at a dose of 0.66 mg/kg/week. Control intervention name : Genotropin INN of the control intervention : somatropin Dosage And administration of the control intervention : Daily SC injections Genotropin (0.025 mg/kg/day). | OPKO Health Inc.(ICCC: EPS International Holdings Co., Ltd) | NULL | complete | 3 | 11 | BOTH | 44 | Phase 3 | Japan |