Ngenla Subcutaneous Injection Special Investigation

Ngenla® Subcutaneous Injection Special Investigation

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.

Study Overview

• Status: Recruiting
• Conditions: Growth Hormone Deficiency Without Epiphyseal Closure
• Intervention / Treatment: Drug: NGENLA (Somatrogon)

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 Type: Observational
• Enrollment (Estimated): 229

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• Japan
  • Tokyo, Japan
    • Recruiting
    • Pfizer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 15 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with GHD without epiphyseal closure who received NGENLA

Description

Patients who satisfy all of the registration criteria are subject to this study.

Registration criteria

1. Patients with GHD without epiphyseal closure who receive this drug for the first time after the date of contract for this study.
2. Boys who are less than 15 years and girls who are less than 13 years of chronological age at the start of treatment with this drug.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
NGENLA (Somatrogon); Patients with GHD without epiphyseal closure who received NGENLA (Somatrogon)	Drug: NGENLA (Somatrogon); Dosage, Frequency: Refer to the latest package insert.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The number of patients reporting Adverse Events (AEs)	up to 5 years
Incidence of Glucose metabolism disorders per exposure period	up to 5 years
Incidence of Neoplasm per exposure period	up to 5 years
Annual growth rate (cm/year)	up to 5 years
Growth rate standard deviation score (SDS) for chronological age	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

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2023
• Primary Completion (Estimated): April 5, 2028
• Study Completion (Estimated): April 5, 2028

Study Registration Dates

• First Submitted: October 27, 2022
• First Submitted That Met QC Criteria: October 27, 2022
• First Posted (Actual): November 2, 2022

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Growth hormone deficiency (GHD); Recombinant human growth hormone (hGH); once-weekly injection; Somatrogon
• Other Study ID Numbers: C0311011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.