Active — Not RecruitingNot Applicable

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

South Korea565 participantsStarted 2024-06-20

Plain-language 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.

Who can participate

Age range3 Years – 19 Years

SexALL

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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

What they're measuring

Incidence of adverse events (AEs)

Timeframe: up to 28 days after last dose

Trial details

NCT IDNCT05509894

SponsorPfizer

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-09-23

View on ClinicalTrials.gov More Pediatric Growth Hormone Deficiency trials