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 | Active Not Recruiting

• 1 other identifier: C0311016
• Study Type: observational
• Target: 565
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Growth Hormone Deficiency

Keywords

Pediatric Growth Hormone Deficiency; Somatrogon

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events (AEs)

  up to 28 days after last dose

Secondary Outcomes (3)

• 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

Study Arms (1)

Participants receiving Ngenla

Participants receiving Ngenla according to label

Drug: Ngenla

Interventions

Ngenla DRUG

As provided in real world practice

Participants receiving Ngenla

Eligibility Criteria

• Age: 3 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study will be performed in patients who have received at least 1 dose of Ngenla® pre-filled pen injection for the following indications as per local product label. (Treatment of children and adolescents from 3 years of age with growth disturbance due to insufficient secretion of growth hormone)

You may qualify if:

• \- 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;
• \. 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer

Seoul, South Korea

Location

Related Links

• To obtain contact information for a study center near you, click here.

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2022
• First Posted: August 22, 2022
• Study Start: June 20, 2024
• Primary Completion (Estimated): September 23, 2026
• Study Completion (Estimated): September 23, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)