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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04633057 | A Study to Evaluating the Efficacy and Safety of Recombinant Long-acting Human Growth Hormone (TJ101) in Children With Growth Hormone Deficiency | PHASE3 | COMPLETED | 168 | — | — | Jan 25, 2021 | Jul 31, 2023 | Apr 15, 2024 | 30 | China |
| Arm | Type | Description |
|---|---|---|
| TJ101 | EXPERIMENTAL | TJ101 1.2 mg/kg once a week for 52weeks |
| NordiFlex | ACTIVE_COMPARATOR | NordiFlex Injection 0.034 mg/kg once a day for 52 weeks |
| Name | Type | Description |
|---|---|---|
| TJ101 | DRUG | TJ101/ Recombinant Human Somatropin Injection treatment: after screening, subjects will be randomized to receive TJ101 1.2 mg/kg once a week until 52 weeks back site, investigator evaluate effectiveness and safety. |
| NordiFlex | DRUG | TJ101/ Recombinant Human Somatropin Injection treatment: after screening, subjects will be randomized to receive Recombinant Human Somatropin Injection 0.034 mg/kg once a day, until 52 weeks back site, investigator evaluate effectiveness and safety. |
Inclusion Criteria: 1. Boys: 3 years ≤ boy's age ≤ 10 years；Girls: 3 years ≤ girl's age ≤ 9 years 2. Pre-pubertal children(Tanner stage I) 3. GHD confirmed by 2 different GH provocation tests with peak GH concentration below 10 ng/mL in screening or one month 4. Height (HT) of at least 2.0 standard...