Genetic Testing of Noonan Subjects Previously Treated With Norditropin®. An Extension to Trial GHNOO-1658
- Registration Number
- NCT01529944
- Lead Sponsor
- Novo Nordisk A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
Inclusion Criteria
- Participation in the GHNOO-1658 trial
- Subject has completed genetic testing of PTPN11 mutation
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Low dose 33 mcg/kg/day somatropin - High dose 66 mcg/kg/day somatropin -
- Primary Outcome Measures
Name Time Method Change in height SDS (Standard Deviation Score) (referenced to normal population) From baseline until final height is reached
- Secondary Outcome Measures
Name Time Method 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 Change in height SDS (referenced to Noonan population) 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 Adverse events From baseline until final height is reached