Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as r-hGH, Somatropin
Saizen A · 1 trial · 1 indication
Final height was defined as the height reached 1 year after height velocity (HV) was less than 2 centimeter/year (cm/year). Height velocity was the change in height since the previous year's measurement. Height was measured with a wall-mounted stadiometer (or in supine position if the participant's age was less than 3 years) and the measurement was repeated thrice by the same observer. The mean of the values obtained in the repeated measurements was taken for the analysis.
HSDS was calculated as height minus reference mean height divided by SD of the reference mean height, both given by the reference growth table (Sempe) for the corresponding chronological age at the height measurement. Greater HSDS indicate greater height. (Sempe M et al., 1979)
| Arm | Type | Description |
|---|---|---|
| Saizen® (Continuous or intermittent treatment) | EXPERIMENTAL | - |
| Saizen® (Observed and then continuous or no treatment) | EXPERIMENTAL | - |
| Observation only | OTHER | - |
| Name | Type | Description |
|---|---|---|
| Saizen® A | DRUG | Continuous or intermittent treatment with recombinant human Growth Hormone (r-hGH) 0.067 milligram/kilogram/day (mg/kg/day) subcutaneously (sc). |
| Saizen® B | DRUG | Observed until the first signs of puberty and then continuous treatment with r-hGH 0.067 mg/kg/day sc or observed without treatment. |
| Observation only | OTHER | Subjects were only observed. |
Inclusion Criteria: * Previous inclusion, good compliance and normal completion of GF4001 or GF6283 in the treatment of growth failure in children born with serious IUGR (3-year continuous r-hGH treatment in GF4001 or 2-year continuous or intermittent r-hGH treatment in GF6283). * Increase in heigh...