Post Marketing Surveillance on Long-term Use With Norditropin® (Short Stature Due to Noonan Syndrome)

Novo Nordisk

Status

Completed

Conditions

Genetic Disorder

Noonan Syndrome

Treatments

Drug: Somatropin

Study type

Observational

Funder types

Industry

Identifiers

NCT03435627

U1111-1191-3084 (Other Identifier)

GHLIQUID-4358

Details and patient eligibility

About

The purpose of this study is to collect information about safety and effectiveness for long term use of Norditropin®. Participants will attend the medical institution according to usual practice and receive medical care, as agreed with the study doctor.

Enrollment

71 patients

Sex

All

Ages

3+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Signed informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
The decision to initiate treatment with commercially available Norditropin® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study.
For non-naïve patients; patients who were previously enrolled in study: GHLIQUID-4020.
For naïve patients; short stature due to Noonan syndrome diagnosed by the physician and a decision to initiate treatment with Norditropin® has been made by the patient/parent and the physician. At study sites, all patients will be registered consecutively from the first patient after approval date (consecutively registered system).
Male or female, 3 years old or over, bone age: less than 17 years old for male / less than 15 years old for female.

Exclusion criteria

Previous participation in this study. Participation is defined as having given informed consent in this study.
Known or suspected allergy to study products or related products.
In case of naïve patients, patients who have received growth hormone (GH) products for treatment of indication other than short stature due to Noonan syndrome before approval date of Noonan indication.