New growth hormone pen under safety watch in korean kids
NCT ID NCT05509894
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tracks the safety and effectiveness of Ngenla, a growth hormone injection, in over 500 children aged 3 and older with growth hormone deficiency in Korea. Researchers will monitor side effects and growth changes over 6 years during routine medical care. The treatment helps manage the condition but does not cure it, as children need ongoing hormone therapy.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 565 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2024
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The study will be performed in patients who have received at least 1 dose of Ngenla® pre-filled pen injection for the following indications as per local product label. (Treatment of children and adolescents from 3 years of age with growth disturbance due to insufficient secretion of growth hormone)
- Ages
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3 to 19 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: \- 1. Children and adolescents from 3 years of age with growth disturbance due to insufficient secretion of growth hormone who have received treatment with somotarogon or have been determined to start treatment with somatrogon according to the approved indications of the medicinal product; 2\. Evidence of a personally signed and dated informed consent document indicating that the patient or their parent(s)/legal guardian, if applicable, have been informed of all pertinent aspects of the study. Exclusion Criteria: 1. Patients concurrently participating in other studies involving therapeutic interventions and/or investigational products; 2. Patients who have contraindications to somatrogon as specified in the approved LPD. 3. Patients with hypersensitivity or case history to somatrogon or to any of the excipients in the product
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Pfizer
Seoul, South Korea
More trials for these conditions
Other studies related to the condition(s) this trial covers.