NCT05602766

Ngenla Subcutaneous Injection Special Investigation

Ngenla® Subcutaneous Injection Special Investigation

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Growth Hormone Deficiency Without Epiphyseal Closure

Interventions

Type	Name	Description
DRUG	NGENLA (Somatrogon)	Dosage, Frequency: Refer to the latest package insert.

Timeline

• Start date: 2023-02-06
• Primary completion: 2029-04-06
• Completion: 2029-04-06
• First posted: 2022-11-02
• Last updated: 2025-10-02

Locations

1 site across 1 country: Japan