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

GHLIQUID-4358

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.

2018-02-26

2022-01-18

2022-01-18

Completed

71

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.

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 71, 'type': 'ACTUAL'}}

2022-11-14