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Clinical Trials in South Korea / NCT05509894
Active, not recruiting Observational

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

NCT05509894 · tracked via the Priya Life Science South Korea tracker
Sponsor
Pfizer
Phase
Observational
Started
2024-06-20
Last updated
2026-01-27

Condition(s) studied

Pediatric Growth Hormone Deficiency

Investigational drug(s) / intervention(s)

Ngenla →

Ngenla: As provided in real world practice

Study summary

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.

Eligibility

Sex
ALL
Min age
3 Years
Max age
19 Years
Healthy volunteers
No
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: 1. Patients concurrently participating in other studies involving therapeutic interventions and/or investigational products; 2. Patients who have contraindications to somatrogon as specified in the approved LPD. 3. Patients with hypersensitivity or case history to somatrogon or to any of the excipients in the product

Primary outcome measure(s)

  • Incidence of adverse events (AEs) — up to 28 days after last dose

Trial sites (1)

FacilityCityRegionStatus
Pfizer Seoul South Korea

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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 NCT05509894 on ClinicalTrials.gov ↗ ← All trials in South Korea