Korean Post-marketing Surveillance Ngenla® Pre-filled Pen Injection for the Treatment of Pediatric Patients With Growth Disturbance Due to Insufficient Secretion of Growth Hormone

Study Overview
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Brief Summary
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This non-interventional study will be performed by design of post-marketing surveillance (PMS) as an additional pharmacovigilance activity of the Risk Management Plan (RMP) for Ngenla® pre-filled pen injection, which is required by the Ministry of Food and Drug Safety (MFDS) according to the local regulation. This post-marketing surveillance will investigate the safety and effectiveness of Ngenla® pre-filled pen injection as the treatment of children and adolescents from 3 years of age with growth disturbance due to insufficient secretion of growth hormone during 6 years under the setting of routine practice in Korea.

Official Title
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Post Marketing Surveillance (PMS) Study for Ngenla Prefilled Pen in Pediatric Patients Who Have Endogenous Growth Failure Due to an Inadequate Secretion of Endogenous Growth Hormone in Korea

Conditions
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Pediatric Growth Hormone Deficiency

Intervention / Treatment
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* Drug: Ngenla


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - 1. Children and adolescents from 3 years of age with growth disturbance due to insufficient secretion of growth hormone who have received treatment with somotarogon or have been determined to start treatment with somatrogon according to the approved indications of the medicinal product; 2. Evidence of a personally signed and dated informed consent document indicating that the patient or their parent(s)/legal guardian, if applicable, have been informed of all pertinent aspects of the study. Exclusion Criteria: Patients concurrently participating in other studies involving therapeutic interventions and/or investigational products; Patients who have contraindications to somatrogon as specified in the approved LPD. Patients with hypersensitivity or case history to somatrogon or to any of the excipients in the product

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants receiving Ngenla<br>Participants receiving Ngenla according to label | Drug: Ngenla<br>* As provided in real world practice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events (AEs) |  | up to 28 days after last dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Annualized Height Velocity in cm/year |  | baseline, up to 12 months | 
| Change from baseline in Height Standard Deviation Score |  | baseline, up to 12 months | 
| Change from baseline in Bone Maturation (BM) |  | baseline, up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric Growth Hormone Deficiency, Somatrogon