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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05509894

Enrollment

565

Registered

2022-08-22

Start date

2024-06-20

Completion date

2026-09-23

Last updated

2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Growth Hormone Deficiency

Keywords

Pediatric Growth Hormone Deficiency, Somatrogon

Brief 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

DRUGNgenla

As provided in real world practice

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

3 Years to 19 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Incidence of adverse events (AEs)	up to 28 days after last dose

Secondary

Measure	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

Countries

South Korea

Contacts

STUDY_DIRECTORPfizer CT.gov Call Center

Pfizer

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026