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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 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 565

Last updated 2026-01-27

No results posted yet for this 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.

Conditions

  • Pediatric Growth Hormone Deficiency

Interventions

DRUG

Ngenla

As provided in real world practice

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Eligibility

Min Age
3 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-20
Primary Completion
2026-09-23
Completion
2026-09-23

Countries

  • South Korea

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05509894 on ClinicalTrials.gov