Table 1.
Patient demographics at baseline (PPS)
| Daily rhGH 0.37 mg/kg/week (n = 14) | LB03002 0.5 mg/kg/week (n = 14) | LB03002 0.7 mg/kg/week (n = 14) | |
|---|---|---|---|
| Age, years | 5.86 (1.29) | 5.36 (1.22) | 6.07 (1.54) |
| Male, n | 10 | 9 | 10 |
| Female, n | 6 | 5 | 6 |
| Birth weight, kg | 3.01 (0.3) | 3.11 (0.29) | 3.01 (0.28) |
| Weight, kg | 17.46 (2.42) | 16.61 (2.43) | 18.94 (6.84) |
| Mid-parental height, cm | 162.55 (7.45) | 164.44 (9.29) | 164.39 (7.44) |
| Height, cm | 105.88 (6.06) | 104.07 (6.23) | 107.47 (8.41) |
| Height SDS for CA | −2.25 (0.3) | −2.28 (0.29) | −2.28 (0.37) |
| Height SDS for CA ≤ −2.25, n | 5 | 8 | 6 |
| BA, years | 5.6 (1.53) | 4.72 (0.82) | 5.49 (1.92) |
| Height SDS for BA | −1.35 (1.28) | −0.69 (1.32) | −0.8 (1.57) |
| Height velocity, cm/year | 6.24 (1.6) | 6.11 (1.3) | 5.51 (0.94) |
| Peak GH plasma conc., ng/mL | 17.55 (10, 85.7) | 17.15 (10.6, 41) | 15.1 (10.1, 26.4) |
| IGF-I, ng/mL | 121 (51.4, 212) | 128 (50.2, 206) | 105 (56.1, 166) |
| IGF-I SDS | −0.67 (−1.39, 0.39) | −0.8 (−2.03, 0.63) | −1.3 (−2.06, 0.15) |
| IGFBP-3, ng/mL | 3,660 (2,200, 4,980) | 3,490 (2,450, 5,910) | 3,655 (2,440, 5,040) |
| IGFBP-3 SDS | 2.2 (−0.17, 5.15) | 2.47 (−0.11, 8.9) | 1.89 (0, 5.27) |
Continuous variables are presented with mean (SD) except peak GH plasma concentration, blood levels of IGF-I and IGFBP-3, and SDS of IGF-I and IGFBP-3, all of which are presented with median (min, max). Mid-parental height (MPH) (cm) was calculated using the following formula: MPH (for boys) = {paternal height + (maternal height + 13)}/2; MPH (for girls) = {(paternal height − 13) + maternal height}/2.