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

NCT05308927 · tracked via the Priya Life Science France tracker

Sponsor

Novo Nordisk A/S

Phase

Observational

Started

2022-03-16

Last updated

2026-10-08

Condition(s) studied

Noonan Syndrome

Investigational drug(s) / intervention(s)

Norditropin →

Norditropin: Patients will be treated with commercially available Norditropin® according to routine clinical practice at the discretion of the treating physician.

Study 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

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

Inclusion Criteria: * 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 Exclusion Criteria: * Patients/Parents/LAR opposed to the collection and processing of their children's medical data * Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation

Primary outcome measure(s)

Change in height standard deviation score — From start of Norditropin® treatment (day 0) until end of follow-up (up to 6 years)
Measured in standard deviation scores (SDS) ranging from -10 to +10

Trial sites (3)

Facility	City	Region
Centre Hospitalier Universitaire D'Angers-2	Angers	France
Ap-Hp-Hopital de Bicetre-2	Le Kremlin-Bicêtre	France
Hopital Des Enfants-2	Toulouse	France

More Novo Nordisk A/S trials in France

Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia With Inhibitors Active, not recruiting

A Research Study to Look at How Well NNC0487-0111 Works Compared to Placebo in People With Heart Failure and Obesity Recruiting

A Research Study Looking at Long-term Treatment With Mim8 in People With Haemophilia A Active, not recruiting

REDEFINE 3: A Research Study to See the Effects of CagriSema in People Living With Diseases in the Heart and Blood Vessels Active, not recruiting

A Study to Evaluate How Well Etavopivat Works in People With Sickle Cell Disease Recruiting

Other trials for the same condition

Constitution of a Biological Collection to Study the Pathophysiology in Noonan Syndrome Recruiting

Link Between Abnormal Bleeding and Coagulation Disorders in Noonan Syndromes Starting soon

A Study of Vosoritide in Children With Noonan Syndrome With Inadequate Growth During or After Human Growth Hormone Treatment Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05308927 on ClinicalTrials.gov ↗ ← All trials in France