Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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...
Saizen A is used for children born with serious intra-uterine growth retardation. It is being developed as a treatment for this condition, which affects growth and development in early childhood.
Saizen A is developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK.
Saizen A is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA for commercial use.
Saizen A has one completed Phase 3 clinical trial, identified as NCT01400698, titled "Saizen in Intra-uterine Growth Retardation." The trial enrolled 91 participants and was a controlled, randomized study.
Yes, Saizen A is a small molecule drug. It is being studied for its effects on children with serious intra-uterine growth retardation.