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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01073605 | Genotropin Treatment in Short Prepubertal Children With Intra-Uterine Growth Retardation | PHASE3 | COMPLETED | 208 | — | — | Jul 1, 1993 | May 1, 2009 | Nov 18, 2010 | 31 | France |
Annual growth rate was expressed as height velocity (centimeter \[cm\]/year). This was derived by substracting annual growth rate at Baseline from 2-year value. (Annual growth rate was calculated each year and rescaled to 1 year if the interval between x and x-1 was not 365 days, as long as a subject remains in the study): ANGRYx = (Height Yx - Height Y{x-1}) / {(Date of Yx - Date of Y{x-1}) /365.25}
| Arm | Type | Description |
|---|---|---|
| Genotonorm A | ACTIVE_COMPARATOR | Continuous 0.7 IU/kg/week or 0.03 mg/kg/day |
| Genotonorm B | ACTIVE_COMPARATOR | Continuous, 1.4 IU/kg/week or 0.06 mg/kg/day |
| Genotonorm C | ACTIVE_COMPARATOR | Intermittent, 1.4 IU/kg/week or 0.06 mg/kg/day |
| Name | Type | Description |
|---|---|---|
| Genotonorm | DRUG | 0.7 IU/kg/week or 0.03 mg/kg/day, daily subcutaneous injection |
Inclusion Criteria: * Chronological age (CA) between 3 and 10 for girls * Chronological age between 3 and 12 for boys * Height for CA below - 2 SD * Birth length for CA below -2SD Exclusion Criteria: * Endocrine disease except well-substituted hypothyroidism * Sever chronic disease * Skeletal dys...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novo Nordisk A/S Sponsored ADR Class B | NVO | 2 | PHASE3 | Somapacitan, Norditropin FlexPro |
| Ascendis Pharma A/S | ASND | 1 | PHASE3 | Lonapegsomatropin, Somatropin Pen Injector |
| Harvard Bioscience, Inc. | HBIO | 1 | NA | Undisclosed |