Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03344458 | A Long-Term Trial Investigating Safety and Efficacy of TransCon hGH in Children With Growth Hormone Deficiency Who Have Completed a Prior TransCon hGH Clinical Trial | PHASE3 | COMPLETED | 298 | — | — | Dec 19, 2017 | Feb 21, 2023 | May 8, 2024 | 42 | United States, Armenia +9 |
| NCT03305016 | A Safety, Tolerability and Efficacy Study of TransCon hGH in Children With Growth Hormone Deficiency | PHASE3 | COMPLETED | 146 | — | — | Nov 13, 2017 | Mar 19, 2019 | Jan 4, 2022 | 24 | United States, Australia +2 |
Long-term safety and tolerability of weekly lonapegsomatropin (TransCon hGH) treatment
Safety and tolerability of weekly lonapegsomatropin (TransCon hGH) treatment
| Arm | Type | Description |
|---|---|---|
| TransCon hGH | EXPERIMENTAL | Once weekly subcutaneous injection of TransCon hGH |
| Name | Type | Description |
|---|---|---|
| TransCon hGH | DRUG | Once weekly subcutaneous injection of TransCon hGH |
Inclusion Criteria: 1. Children who have completed a prior phase 3 TransCon hGH trial 2. Children who have not permanently discontinued study drug in the prior trial 3. Written, signed, informed consent of the parent or legal guardian of the subject and written assent of the subject as required by ...