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

Pediatric Growth Hormone Deficiency Clinical Trial

Official 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05509894
• Other study ID #: C0311016
• Status: Not yet recruiting
• Start date: June 30, 2024
• Est. completion date: January 3, 2028

Study information

• Verified date: June 2024
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 565
• Est. completion date: January 3, 2028
• Est. primary completion date: January 3, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Pediatric Growth Hormone Deficiency

Intervention

Drug:
• Ngenla
As provided in real world practice

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events (AEs)		up to 28 days after last dose
Secondary	Change from baseline in Annualized Height Velocity in cm/year		baseline, up to 12 months
Secondary	Change from baseline in Height Standard Deviation Score		baseline, up to 12 months
Secondary	Change from baseline in Bone Maturation (BM)		baseline, up to 12 months