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Clinical Trials in Japan / NCT05602766
Active, not recruiting Observational

Ngenla Subcutaneous Injection Special Investigation

NCT05602766 · tracked via the Priya Life Science Japan tracker
Sponsor
Pfizer
Phase
Observational
Started
2023-02-06
Last updated
2026-10-07

Condition(s) studied

Growth Hormone Deficiency Without Epiphyseal Closure

Investigational drug(s) / intervention(s)

NGENLA (Somatrogon) →

NGENLA (Somatrogon): Dosage, Frequency: Refer to the latest package insert.

Study 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.

Eligibility

Sex
ALL
Min age
—
Max age
15 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
Pfizer Tokyo Japan

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05602766 on ClinicalTrials.gov ↗ ← All trials in Japan