Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Somatropin · 4 trials · 5 indications
Height was measured using a wall mounted device (example, Harpenden stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS CA Yx = (height Yx - reference mean for CA Yx) / reference SD for CA Yx; Yx refers to the value at particular timepoint x. Height in SDS was calculated using Sempe reference means and SD for height. CA calculated as integer (Date of height measurement-Date of birth)/365.25\*12.
Height was measured using a wall mounted device (example, Harpenden stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS CA Yx = (height Yx - reference mean for CA Yx) / reference SD for CA Yx; Yx refers to the value at particular timepoint x. Height in SDS was calculated using Sempe reference means and SD for height. CA calculated as integer (Date of height measurement-Date of birth)/365.25\*12.
Change in annual growth rate (AGR) standard deviation score (SDS) for chronological age (CA) derived by subtracting AGR SDS CA at baseline from each time point (Yx) value. AGR at Yx= (height Yx-height Y\[x-1\])/(\[date of Yx-date of Y{x-1}\]/365.25). AGR as SDS calculated using Sempe reference means and standard deviations (SD) for growth rate. AGR SDS CA (for both baseline and Yx)= (AGR-reference mean for growth rate CA)/reference SD for growth rate CA. CA calculated as integer (Date of height measurement-Date of birth)/365.25\*12. SDS indicates how similar participant was to reference population.
Change in annual growth rate (AGR) standard deviation score (SDS) for chronological age (CA) derived by subtracting AGR SDS CA at baseline from each time point (Yx) value. AGR at Yx= (height Yx-height Y\[x-1\])/(\[date of Yx-date of Y{x-1}\]/365.25). AGR as SDS calculated using Sempe reference means and standard deviations (SD) for growth rate. AGR SDS CA (for both baseline and Yx)= (AGR-reference mean for growth rate CA)/reference SD for growth rate CA. CA calculated as integer (Date of height measurement-Date of birth)/365.25\*12. SDS indicates how similar participant was to reference population.
Change in Height SDS after 1 year where SDS=height minus mean (age-and sex-matched reference) divided by SD (age and sex-matched reference).
Change in Growth Velocity (GV) SDS after 1 year where SDS=GV minus mean (age-and sex-matched reference) divided by SD (age and sex-matched reference).
| Arm | Type | Description |
|---|---|---|
| Somatropin | EXPERIMENTAL | - |
| Treatment Arm | ACTIVE_COMPARATOR | - |
| Control Arm | NO_INTERVENTION | - |
| Name | Type | Description |
|---|---|---|
| Somatropin | DRUG | Liquid, daily, during 3 years and extended to 5 years Dosage: 0,46 mg/kg/week - the maximum dose should not exceed 50 µg/kg/day |
| Control Arm | OTHER | Controlled, prospective, randomized, multicenter study with an untreated (control) group during the first year. The children will be randomized into treatment or untreated (control) group. After one year the control group will undergo GH-therapy, too. The study will end after 2 and 3 years of observation, respectively. Children randomized to the control group will get the possibility to continue treatment for a further year. |
Inclusion Criteria: * Glucocorticosteroid treatment for 12 months at least * Bone age \< 15 years for a boy and \< 13 years for a girl * Child measured height \< - 2 SD, Child currently treated by GH Exclusion Criteria: * Known diabetes (type 1 or type 2) * A previous history of intolerance or hy...
Somatropin is used for growth hormone therapy in children with growth hormone deficiency and endocrine system diseases, including growth retardation. It is a small molecule being developed by Pfizer, Inc. for conditions related to growth hormone deficiency and short stature.
Somatropin is developed by Pfizer, Inc., a company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is being investigated for use in growth hormone therapy and related endocrine conditions.
Somatropin is in Phase 3 clinical development for growth hormone deficiency and endocrine system diseases. It is an investigational drug and has not been approved by the FDA. Clinical trials are completed, with no active trials currently ongoing.
Somatropin has completed Phase 3 trials including NCT00163189, NCT00163215, and NCT00174278, which studied its effects on growth retardation in children with growth hormone deficiency and endocrine diseases. A Phase 2 trial, NCT00174460, examined its use in children born preterm.
Somatropin is a small molecule used for growth hormone therapy. It is designed to address growth hormone deficiency by providing exogenous growth hormone to stimulate growth in children with growth retardation due to various endocrine conditions.