HomeTrialNCT05509894
🔬NCT05509894ACTIVE NOT RECRUITING

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 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.

Interventions / Drugs
View on ClinicalTrials.gov ↗
Study Details
Enrollment565 participants
Primary Completion
Lead SponsorPfizer
Data Retrieved2026-04-11 02:55:53.190001+00:00
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