French Registry of Children Treated With Norditropin® for Short Stature Associated With Noonan Syndrome

Status: Enrolling by invitation
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Observational
SUMMARY

This is a non-interventional registry of children treated with Norditropin® for short stature due to Noonan Syndrome (NS). This study aims to provide data on long-term growth evolution and safety of Norditropin® as well as Health Related Quality of Life (HRQoL) data. This registry will include the entirety of children treated with Norditropin® for short stature due to NS over the inclusion period. The decision to initiate treatment with commercially available Norditropin® is made by the patient/parents/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: No
View:

• Patients with a clinical and/or genetic diagnosis of NS

• Patients who are treated with Norditropin® (already treated or initiating) and who are followed in a participating center

• The decision to initiate treatment with commercially available Norditropin® has been made by the patient/parents/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study

Locations
Other Locations
France
Novo Nordisk Investigational Site
Le Kremlin-bicetre
Novo Nordisk Investigational Site
Toulouse Cedex 9
Time Frame
Start Date: March 16, 2022
Estimated Completion Date: March 17, 2028
Participants
Target number of participants: 221
Treatments
Incident patients
Children initiated Norditropin® upon their inclusion in the study but independently from the decision to participate in this study
Prevalent patients - finished growth upon inclusion
Children were already treated with Norditropin® before their inclusion in the study and finished their growth upon their inclusion. Data collected retrospectively from medical records
Prevalent patients - not finished growth upon inclusion
Children were already treated with Norditropin® before their inclusion in the study and did not finish their growth upon inclusion. Data collected both retrospectively and prospectively
Sponsors
Leads: Novo Nordisk A/S

This content was sourced from clinicaltrials.gov