Genetic Disorder, Noonan Syndrome
Conditions
Brief summary
This trial is conducted in Europe. The aim of this trial is to obtain the PTPN11 mutation status and investigate the impact of the PTPN11 mutation status on the effect of somatropin (Norditropin®) by use of data obtained in the GHNOO-1658 trial.
Interventions
DRUGsomatropin
Results from a genetic testing for the PTPN11 mutation will be collected retrospectively for 24 subjects with Noonan syndrome previously treated with somatropin in accordance with the S/GHD/004/N00 protocol and in the follow-up trial GHNOO-1658.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Participation in the GHNOO-1658 trial * Subject has completed genetic testing of PTPN11 mutation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in height SDS (Standard Deviation Score) (referenced to normal population) | From baseline until final height is reached |
Secondary
| Measure | Time frame |
|---|---|
| Final height SDS (referenced to normal population) | From baseline until final height is reached |
| Final height SDS (referenced to Noonan population) | From baseline until final height is reached |
| Adverse events | From baseline until final height is reached |
| Number of subjects with final height SDS above - 2SDS (reference to normal population) | When final height is reached |
| Proportion of subjects with final height SDS above - 2SDS (reference to normal population) | When final height is reached |
| Change in height SDS (referenced to Noonan population) | From baseline until final height is reached |
Countries
Sweden
Outcome results
None listed