Genetic Disorder, Growth Hormone Deficiency in Children, Growth Hormone Disorder, Turner Syndrome
Conditions
Brief summary
This trial is conducted in Asia. The aim of this trial is to evaluate the new liquid somatropin formulation in children with growth hormone deficiency.
Interventions
DRUGsomatropin
Dosed by individual needs as judged by the Investigator (trial physician). Injected subcutaneously (s.c./under the skin)
Sponsors
Novo Nordisk A/S
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Written Informed Consent by patient and/or guardian/parents * Patients with one of the following diagnosis: Growth failure due to growth hormone deficiency (GHD), Turner syndrome, or growth retardation in children with chronic renal disorders * Patients who are willing to inject themselves and answer questionnaires or young patients whose parents/guardian are willing to inject their child and answer questionnaires * Patients on growth hormone therapy for at least 6 weeks before entering the trial
Exclusion criteria
* Pregnancy or breast feeding women * Suspected or known allergy to trial product * Other daily injection therapy (non-growth hormone, e.g insulin-therapy) * Participating in any other trial involving other investigational products within the last 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient acceptance of the new liquid growth hormone formulation | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of Adverse Events (AE) | — |
| Number of Serious Adverse Events (SAE) | — |
Countries
Israel
Outcome results
None listed