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NCT Number: NCT05509894

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Pediatric Growth Hormone Deficiency

Age range

3 year–19 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;
  • 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

  • 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

Treatment and study plan

Ngenla

Drug

As provided in real world practice

Primary outcomes

  1. Incidence of adverse events (AEs)

    Time frame: up to 28 days after last dose

Secondary outcomes

  1. Change from baseline in Annualized Height Velocity in cm/year

    Time frame: baseline, up to 12 months

  2. Change from baseline in Height Standard Deviation Score

    Time frame: baseline, up to 12 months

  3. Change from baseline in Bone Maturation (BM)

    Time frame: baseline, up to 12 months

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 22, 2022
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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