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

Active, not recruiting

• Conditions: Pediatric Growth Hormone Deficiency
• Interventions: Drug: Ngenla

• Registration Number: NCT05509894
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-19
• Study First Submitted QC: 2022-08-19
• Study First Posted: 2022-08-22
• Study Start: 2024-06-20
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-18
• Primary Completion: 2028-01-03
• Study Completion: 2028-01-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 565

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants receiving Ngenla	Ngenla	Participants receiving Ngenla according to label

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events (AEs)	up to 28 days after last dose

Secondary Outcome Measures

Name	Time	Method
Change from baseline in Annualized Height Velocity in cm/year	baseline, up to 12 months
Change from baseline in Bone Maturation (BM)	baseline, up to 12 months
Change from baseline in Height Standard Deviation Score	baseline, up to 12 months

Trial Locations

Locations (1)

Pfizer; 🇰🇷 Seoul, Korea, Republic of