Genotropin®) is approved for treatment of short statured children in specific indications. A benefit can also be achieved in other pathological conditions that lead to growth retardation. Because only few data or only case reports are available in these conditions improvement of growth rate should be shown by this study.
Conditions
Interventions
Product Name: Genotropin® (Somatropin)
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Somatropin
Concentration unit: mg milligram(s)
Concentration type: equal
Sponsors
Childrens´ Hospital Erlangen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria for request of GH treatment: Severe growth retardation ( 4 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria for request of GH treatment: Participation in any other clinical study Unable to follow the and/or comprehend the protocol ( e.g. severe mental retardation) Previous history of intolerance or hypersensitivity to the study drug History of malignancy Chromosomal anomalies with increased risk for malignancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary: To show an improvement of height, change in height (SDS) under GH treatment one year after visit 2 (start of GH therapy). ;Secondary Objective: Secondary: To show an increase in height velocity >1 SD compared to pretreatment height velocity and to confirm good clinical and biological safety of GH treatment in these patients (e.g. adverse events, serum IGF-I, fasting blood glucose and insulin). ;Primary end point(s): Primary Efficacy Variable: Increase in height (SDS) Secondary Efficacy Variable: height velocity (SDS) and safety on GH treatment | — |
Countries
Germany
Outcome results
None listed