Active — Not RecruitingNot Applicable

Ngenla Subcutaneous Injection Special Investigation

Japan1 participantsStarted 2023-02-06

Plain-language 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.

Who can participate

Age range

15 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The number of patients reporting Adverse Events (AEs)

Timeframe: up to 5 years

Incidence of Glucose metabolism disorders per exposure period

Timeframe: up to 5 years

Incidence of Neoplasm per exposure period

Timeframe: up to 5 years

Annual growth rate (cm/year)

Timeframe: up to 5 years

Growth rate standard deviation score (SDS) for chronological age

Timeframe: up to 5 years

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

Timeframe: up to 5 years

Proportion of reported Adverse Events

Timeframe: up to 5 years

Trial details

NCT IDNCT05602766

SponsorPfizer

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2029-04-06

View on ClinicalTrials.gov More Growth Hormone Deficiency Without Epiphyseal Closure trials

Plain-language summary

Who can participate

Age range

15 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

The number of patients reporting Adverse Events (AEs)

Timeframe: up to 5 years

Incidence of Glucose metabolism disorders per exposure period

Timeframe: up to 5 years

Incidence of Neoplasm per exposure period

Timeframe: up to 5 years

Annual growth rate (cm/year)

Timeframe: up to 5 years

Growth rate standard deviation score (SDS) for chronological age

Timeframe: up to 5 years

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

Timeframe: up to 5 years

Proportion of reported Adverse Events

Timeframe: up to 5 years