Ngenla Subcutaneous Injection Special Investigation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to learn about the long-term safety and effects of Ngenla. Ngenla is approved for treatment of GHD (Growth hormone deficiency) without epiphyseal closure under daily medical practice. Registration criteria of this study are the patients who: Have GHD without epiphyseal closure and receiving Ngenla for the first time. Are boys less than 15 years or girls less than 13 years of age at the start of treatment with Ngenla. All patients in this study will receive Ngenla according to the prescriptions. We will examine their experiences for a long time. This will help us to determine the safety and effects of Ngelna for long-term use. Patients will be followed up from the date of first Ngenla treatment until November 30, 2027.

Detailed Description
-----------------
This is a multi-center cohort study in patients with GHD without epiphyseal closure receiving NGENLA® Subcutaneous Injection. The investigators complete the case report form (CRF) based on the information extracted from the medical record created in daily medical practice.

Official Title
-----------------
Ngenla® Subcutaneous Injection Special Investigation

Conditions
-----------------
Growth Hormone Deficiency Without Epiphyseal Closure

Intervention / Treatment
-----------------
* Drug: NGENLA (Somatrogon)


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients who satisfy all of the registration criteria are subject to this study. Registration criteria Patients with GHD without epiphyseal closure who receive this drug for the first time after the date of contract for this study. Boys who are less than 15 years and girls who are less than 13 years of chronological age at the start of treatment with this drug.

Ages Eligible for Study
-----------------
Maximum Age: 15 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NGENLA (Somatrogon)<br>Patients with GHD without epiphyseal closure who received NGENLA (Somatrogon) | Drug: NGENLA (Somatrogon)<br>* Dosage, Frequency: Refer to the latest package insert.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of patients reporting Adverse Events (AEs) |  | up to 5 years | 
| Incidence of Glucose metabolism disorders per exposure period |  | up to 5 years | 
| Incidence of Neoplasm per exposure period |  | up to 5 years | 
| Annual growth rate (cm/year) |  | up to 5 years | 
| Growth rate standard deviation score (SDS) for chronological age |  | up to 5 years | 
| Change in height SDS for chronological age and time-course of height SDS for chronological age |  | up to 5 years | 
| Proportion of reported Adverse Events |  | up to 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Growth hormone deficiency (GHD), Recombinant human growth hormone (hGH), once-weekly injection, Somatrogon