Back to resultsGenetic Testing of Noonan Subjects Previously Treated With Norditropin®. An Extension to Trial GHNOO-1658
Primary Purpose
Genetic Disorder, Noonan Syndrome
Status
Completed
Phase
Phase 3
Locations
Sweden
Study Type
Interventional
Intervention
somatropin
somatropin
Sponsored by
About this trial
This is an interventional treatment trial for Genetic Disorder
Eligibility Criteria
Inclusion Criteria:
- Participation in the GHNOO-1658 trial
- Subject has completed genetic testing of PTPN11 mutation
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Low dose 33 mcg/kg/day
High dose 66 mcg/kg/day
Arm Description
Outcomes
Primary Outcome Measures
Change in height SDS (Standard Deviation Score) (referenced to normal population)
Secondary Outcome Measures
Final height SDS (referenced to normal population)
Final height SDS (referenced to Noonan population)
Change in height SDS (referenced to Noonan population)
Number of subjects with final height SDS above - 2SDS (reference to normal population)
Proportion of subjects with final height SDS above - 2SDS (reference to normal population)
Adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01529944
Brief Title
Genetic Testing of Noonan Subjects Previously Treated With Norditropin®. An Extension to Trial GHNOO-1658
Official Title
Genetic Testing of Noonan Subjects Previously Treated With Norditropin® in the GHNOO-1658 Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genetic Disorder, Noonan Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low dose 33 mcg/kg/day
Arm Type
Experimental
Arm Title
High dose 66 mcg/kg/day
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
somatropin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
somatropin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in height SDS (Standard Deviation Score) (referenced to normal population)
Time Frame
From baseline until final height is reached
Secondary Outcome Measure Information:
Title
Final height SDS (referenced to normal population)
Time Frame
From baseline until final height is reached
Title
Final height SDS (referenced to Noonan population)
Time Frame
From baseline until final height is reached
Title
Change in height SDS (referenced to Noonan population)
Time Frame
From baseline until final height is reached
Title
Number of subjects with final height SDS above - 2SDS (reference to normal population)
Time Frame
When final height is reached
Title
Proportion of subjects with final height SDS above - 2SDS (reference to normal population)
Time Frame
When final height is reached
Title
Adverse events
Time Frame
From baseline until final height is reached
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participation in the GHNOO-1658 trial
Subject has completed genetic testing of PTPN11 mutation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
City
Göteborg
ZIP/Postal Code
416 85
Country
Sweden
12. IPD Sharing Statement
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Genetic Testing of Noonan Subjects Previously Treated With Norditropin®. An Extension to Trial GHNOO-1658
We'll reach out to this number within 24 hrs