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

Pfizer

Status

Active, not recruiting

Conditions

Pediatric Growth Hormone Deficiency

Treatments

Drug: Ngenla

Study type

Observational

Funder types

Industry

Identifiers

NCT05509894

C0311016

Details and patient eligibility

About

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.

Enrollment

565 estimated patients

Sex

All

Ages

3 to 19 years old

Volunteers

No 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;

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