Growth Hormone Disorders
Conditions
Brief summary
This study is a multicenter, open label, observational, post marketing surveillance study of NutropinAq® in Austria, France, Germany, Italy, Spain, Romania and United Kingdom to collect long-term safety and effectiveness information on NutropinAq® during treatment of paediatric growth disorders.
Detailed description
The objective of this study is to collect long term safety and effectiveness information on Ipsen's growth hormone (GH) NutropinAq® regarding treatment of paediatric growth disorders for which GH is indicated.
Interventions
None listed
Sponsors
Ipsen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
* Children of either sex who are treated with NutropinAq® for the treatment of growth failure * Patients who are willing to comply with follow-up appointments throughout study participation * Written informed consent signed by both parents or by the liable parent or by the legal guardian when applicable, and by the child when applicable
Exclusion criteria
* Patients not treated with NutropinAq® * Patients with closed epiphyses * Patients with active neoplasia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events | Every 3 months until study completion | Description and incidence of any Serious Adverse Event (SAE) and all related (serious and non-serious) Adverse Events (AEs). |
Secondary
| Measure | Time frame |
|---|---|
| Treatment height measurements until epiphyseal closure is achieved. | Every 3 months until study completion |
Countries
United Kingdom
Outcome results
None listed