Ngenla Subcutaneous Injection Special Investigation

Active, not recruiting

• Conditions: Growth Hormone Deficiency Without Epiphyseal Closure
• Interventions: Drug: NGENLA (Somatrogon)

• Registration Number: NCT05602766
• Lead Sponsor: Pfizer

Brief Summary

The purpose of this study is to learn about the long-term safety and effects of Ngenla. Ngenla is approved for treatment of GHD (Growth hormone deficiency) without epiphyseal closure under daily medical practice.

Registration criteria of this study are the patients who:

* Have GHD without epiphyseal closure and receiving Ngenla for the first time.

* Are boys less than 15 years or girls less than 13 years of age at the start of treatment with Ngenla.

All patients in this study will receive Ngenla according to the prescriptions. We will examine their experiences for a long time. This will help us to determine the safety and effects of Ngelna for long-term use.

Patients will be followed up from the date of first Ngenla treatment until November 30, 2027.

Detailed Description

This is a multi-center cohort study in patients with GHD without epiphyseal closure receiving NGENLA® Subcutaneous Injection. The investigators complete the case report form (CRF) based on the information extracted from the medical record created in daily medical practice.

Study Timeline

• Study First Submitted: 2022-10-27
• Study First Submitted QC: 2022-10-27
• Study First Posted: 2022-11-02
• Study Start: 2023-02-06
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-14
• Primary Completion: 2029-04-06
• Study Completion: 2029-04-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NGENLA (Somatrogon)	NGENLA (Somatrogon)	Patients with GHD without epiphyseal closure who received NGENLA (Somatrogon)

Primary Outcome Measures

Name	Time	Method
Incidence of Glucose metabolism disorders per exposure period	up to 5 years
Growth rate standard deviation score (SDS) for chronological age	up to 5 years
The number of patients reporting Adverse Events (AEs)	up to 5 years
Incidence of Neoplasm per exposure period	up to 5 years
Annual growth rate (cm/year)	up to 5 years
Change in height SDS for chronological age and time-course of height SDS for chronological age	up to 5 years
Proportion of reported Adverse Events	up to 5 years

Trial Locations

Locations (1)

Pfizer; 🇯🇵 Tokyo, Japan