growth failure associated with: - inadequate growth hormone secretion - Turner syndrome, confirmed by karyotype - chronic renal insufficiency up to renal transplantation
Conditions
Interventions
Trade Name: NutropinAq 10 mg/2 ml solution for injection in a cartridge
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Somatropin
Concentration unit: mg/ml milligram(s)/millilitre
Co
Sponsors
Beaufour Ipsen Pharma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Children (boys and girls under 18) with growth failure associated with: - inadequate growth hormone secretion - Turner syndrome, confirmed by karyotype - chronic renal insufficiency up to renal transplantation Written informed consent signed by both parents or by the liable parent or by the legal guardian when applicable AND the child when applicable Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Children with hypersensitivity to somatropin or any of the excipients Children with closed epiphyses Children with active neoplasm Children with acute critical illness due to surgery, multiple accidental trauma Children with acute respiratory failure Children having received any unlicensed drug within the previous 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish an optimal monitoring regimen for IGF-I in NutropinAq treated children, using a newly developed capillary blood spot IGF-I measurements technology.;Secondary Objective: 1.To assess under clinical practice conditions, the biological variability of IGF-I (if any) in children treated with NutropinAq (physiological intra-individual variations, timing, dose of NutropinAq) and in different diseases conditions 2. Assuming a significant biological variability is observed, to identify parameters contributing to or related to this variability 3. To further validate the filter paper versus serum method IGF-I assay in the study setting 4. To assess auxological parameters during treatment with NutropinAq 5. To assess the acceptability of the NutropinAq Pen ;Primary end point(s): The number of capillary blood spot IGF-I measurements and the optimal timing of samples to assess the IGF-I status of NutropinAq treated patients | — |
Countries
Austria, Denmark, Finland, Italy, Spain, Sweden
Outcome results
None listed