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Active, Not Recruiting

NCT Number: NCT05602766

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Growth Hormone Deficiency Without Epiphyseal Closure Bone Diseases Bone Diseases, Developmental Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Dwarfism Dwarfism, Pituitary Endocrine System Diseases Hypopituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

Up to 15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer

Tokyo, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Registration criteria

  • Patients with GHD without epiphyseal closure who receive this drug for the first time after the date of contract for this study.
  • 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.

Treatment and study plan

NGENLA (Somatrogon)

Drug

Dosage, Frequency: Refer to the latest package insert.

Primary outcomes

  1. The number of patients reporting Adverse Events (AEs)

    Time frame: up to 5 years

  2. Incidence of Glucose metabolism disorders per exposure period

    Time frame: up to 5 years

  3. Incidence of Neoplasm per exposure period

    Time frame: up to 5 years

  4. Annual growth rate (cm/year)

    Time frame: up to 5 years

  5. Growth rate standard deviation score (SDS) for chronological age

    Time frame: up to 5 years

  6. Change in height SDS for chronological age and time-course of height SDS for chronological age

    Time frame: up to 5 years

  7. Proportion of reported Adverse Events

    Time frame: up to 5 years

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Ngenla® Subcutaneous Injection Special Investigation

Important dates

Study start
2023
Primary completion
2029
Study completion
2029
First posted
Nov 2, 2022
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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